Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Overactive Bladder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02820844

Enrollment

250

Registered

2016-07-01

Start date

2016-08-10

Completion date

2018-11-12

Last updated

2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

Keywords

Overactive bladder, Botulinum toxin type A, Urinary incontinence

Brief summary

GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of overactive bladder (OAB) in several countries, however, it has not been approved for OAB treatment in Japan. This study has been planned to evaluate the efficacy and safety of GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been adequately managed with other medications for OAB. The primary objective of this study is to evaluate the superiority of a single dose treatment of GSK1358820 100 units (U) compared with placebo. The study comprises a screening phase up to 28 days, followed by a double-blind treatment phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within the treatment arms according to the number of urinary urge incontinence episodes during screening. Subjects meeting the criteria for re-treatment will receive a second and third treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be spaced at least 12 weeks from the previous treatment. The total duration of participation for any subject will not exceed 52 weeks, including screening and the 48-week treatment period.

Interventions

DRUGGSK1358820

GSK1358820 injection contains botulinum toxin type A (100 U), sodium chloride (0.9 milligrams \[mg\]), and human serum albumin (0.5 mg). 10 mL of the drug will be injected at 20 sites (0.5 mL at each site) in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered under local anesthesia, via cystoscopy. Permitted anesthesia options for cystoscopy are intraurethral lidocaine (or similar) gel, and for treatment administration, installation of 1-2% lidocaine (or similar anesthetic) into the bladder.

DRUGPlacebo

Placebo injection is made up of sodium chloride (0.9 mg). 10 mL of the injection will be injected at 20 sites (0.5 mL at each site) in the detrusor muscle, spaced approximately 1 cm apart. The injection will be administered under local anesthesia, via cystoscopy. Permitted anesthesia options for cystoscopy are intraurethral lidocaine (or similar) gel, and for treatment administration, installation of 1-2% lidocaine (or similar anesthetic) into the bladder.

DRUGAntibiotic therapy

Subjects will use prophylactic antibiotic therapy approved for the indication of UTIs, at the discretion of the investigator, with the exception of those in the class of aminoglycosides. The therapy will begin 1 to 3 days prior to the administration of study treatment, and continue for 1 to 3 days following the treatment.

OTHERBladder diary

The bladder diary is a self-reporting tool to record subject's data on micturition. Subjects will enter data in the diary over 3 consecutive days. During Screening, data will be collected within 28 days prior to first treatment. During treatment periods, data will be collected within a week prior to each scheduled visit. The bladder diary will capture the following information: 1) Date and time of urinary episode, 2) episodes of micturition, 3) episodes of urinary incontinence, 4) episodes of urgency, 5) intensity of urgency, 6) episodes of nocturia, 7) use of CIC, and 8) urine volume. Diary data will not be collected when a subject experiences symptoms of a UTI.

OTHERKing's Health Questionnaire (KHQ)

The KHQ will assess the impact of urinary incontinence on QOL. It is a questionnaire with 21 items and the following 9 domains: 1) General health, 2) Incontinence impact, 3) Role limitations, 4) Physical limitations, 5) Social limitations, 6) Personal relationships, 7) Emotion, 8) Sleep/energy, 9) Severity measure. The items are answered by subjects themselves, and scores are summated using a defined algorithm.

OTHEROveractive Bladder Symptom Score (OABSS)

The OABSS will comprehensively assess symptoms of OAB, such as frequency of micturition, nocturia, urinary urgency, and urge incontinence. It consists of 4 questions which will be responded by subjects themselves, by selecting the most appropriate answer for each question.

OTHERTreatment Benefit Scale (TBS)

The TBS consists of one question (My condition has), to which the subject will answer by selecting one of the following responses: greatly improved, improved, not changed, worsened. The TBS will assess treatment benefit of GSK1358820.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Aged \>=20 years at the time of signing the informed consent. * Subject has symptoms of OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented subject history. * Subject has not been adequately managed with one or more medications (that is, anticholinergics or beta-3 adrenergic receptor agonist) for treatment of their OAB symptom. 'Not adequately managed' is defined as: An inadequate response after at least a 4-week period of OAB medication(s) on an approved optimized dose(s), that is, subject is still incontinent despite medication(s) for OAB; or limiting side effects (that is, condition that subject reduced dosage or discontinued the medication due to side effect after at least a 2-week period of OAB medication(s) on an approved optimized dose(s)). * Subject who experiences all of the following, in the 3-day subject bladder diary completed during the screening phase: 1. \>= 3 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day 2. urinary frequency (defined as an average of \>= 8 micturitions \[toilet voids\] per day, that is, a total of \>= 24 micturitions) * Subject is willing to use clean intermittent catheterization (CIC) to drain urine if it is determined to be necessary by the investigator (or subinvestigator). * Body weight \>=40 kilograms (kg) at screening. * Males or females: 1. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until the study exit: * Vasectomy with documentation of azoospermia. * Male condom plus partner use of one of the contraceptive options below: Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness criteria including a \<1% rate of failure per year, as stated in the product label; or oral contraceptive, either combined or progestogen alone. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. 2. Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine or serum human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. • Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until the study exit. This list of highly effective methods (approved in Japan) is provided below, and it does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis: Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a \<1% rate of failure per year, as stated in the product label; Oral Contraceptive, either combined or progestogen alone; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. * Subject has given signed informed consent, including compliance with the requirements and restrictions listed in the consent form and in this protocol (example, using the toilet without assistance, complete bladder diaries and questionnaires, is able to collect volume voided per micturition measurements over a 24-hour period, and attend all study visits in the opinion of the investigator (or subinvestigator).

Exclusion criteria

* Subject has symptoms of OAB due to any known neurological reason (example, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.) * Subject has a predominance of stress incontinence determined by subject history. * Subject has a history or evidence of any diseases, functional abnormalities or bladder surgery, other than OAB, that may have affected bladder function including but not limited to: 1. Bladder stones (including bladder stone surgery) within 6 months prior to screening or confirmed occurrence of bladder stones at the screening phase 2. Surgery (including minimally invasive surgery) within 1 year of screening for stress incontinence or pelvic organ prolapse 3. Current use of an electrostimulation/neuromodulation device for treatment of urinary incontinence. Note: Use of any implantable device is prohibited within 4 weeks prior to initiation of screening phase and throughout the study period. Use of any external device is prohibited within 7 days prior to the start of the screening phase 4. History of interstitial cystitis, in the opinion of the investigator (or subinvestigator) 5. Past or current evidence of hematuria due to urological/renal pathology or uninvestigated hematuria. Subjects with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction by the investigator (or subinvestigator). 6. Past or current history of bladder cancer or other urothelial malignancy, positive result of urine cytology or uninvestigated suspicious urine cytology results at the Screening phase. Suspicious urine cytology abnormalities require that bladder cancer or other urothelial malignancy has been ruled out to the satisfaction of the investigator according to local site practice. 7. An active genital infection, other than genital warts, either concurrently or within 4 weeks prior to Screening 8. Male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of \>10 nanograms (ng)/mL at Screening. Subjects with a PSA level of \>= 4 ng/mL but \<= 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator (or subinvestigator) according to local site practice. 9. Evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator (or subinvestigator) * Subject has a history of 2 or more urinary tract infections (UTIs) within 6 months of initiation of Treatment phase 1 (Week 0) or current administration of prophylactic antibiotics to prevent chronic UTIs * Subject has a positive urine dipstick reagent strip test at initiation of Treatment phase 1 (Week 0) for nitrites or leukocyte esterase, or who are considered by the investigator (or subinvestigator) to have UTI. * Subject has a serum creatinine level \>2 times the upper limit of normal (ULN) at screening. * Alanine aminotransferase (ALT) \> 2xULN; and bilirubin \> 1.5xULN (isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) at screening. * Subject has current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Notes: 1. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis 2. Chronic stable hepatitis B and C (example, presence of hepatitis B surface antigen \[HBsAg\] or positive hepatitis C antibody \[HCVAb\] test result within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria * QT corrected (QTc) \> 450 milliseconds (msec) or QTc \> 480 msec in subjects with Bundle Branch Block from the result of electrocardiogram (ECG) at screening. Notes: 1. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read 2. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial * Subject has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis. * Subject received anticholinergic, beta-3 adrenergic receptor agonist or any other medications or therapies to treat symptoms of OAB, including nocturia, within 7 days prior to the start of the screening phase. * Subject has been treated with any intravesical pharmacologic agent (example, capsaicin, resiniferatoxin) for OAB symptoms within 12 months prior to initiation of Treatment phase 1 (Week 0). * Subject has previous or current use of botulinum toxin therapy of any serotype for the treatment of any urological condition. * Subject has previous use within 12 weeks prior to initiation of Treatment phase 1 (Week 0) or current use of botulinum toxin therapy of any serotype for any non-urological condition or beauty care. * Subject has been immunized for botulinum toxin of any serotype. * Subject cannot withhold any antiplatelet or anticoagulant therapy or medications with anticoagulative effects for 3 days prior to initiation of Treatment phase 1 (Week 0). Some medications may need to be withheld for \>3 days, per clinical judgment of the investigator (or subinvestigator). * Subject has not initiated appropriate antibiotic medication 1 to 3 days prior to the initiation of Treatment phase 1 (Week 0). * Subject uses CIC or indwelling catheter to manage their urinary incontinence. * Subject has a history of sensitivity to any of the study medications, medications used in the study (including anesthesia), or their components or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * Subject has any medical condition that may put them at increased risk with exposure to GSK1358820 including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis. * Females who are pregnant, nursing or planning a pregnancy during the study. * Subject has a PVR urine volume of \>100 mL at screening phase. The PVR measurement can be repeated once; the subject is to be excluded if the repeated measure is above 100 mL. * Subject has had urinary retention or an elevated PVR urine volume within 6 months of screening that has been treated with an intervention (such as catheterization). Voiding difficulties as a result of surgical procedures that resolved within 24 hours are not exclusionary. * Subject has a 24-hour total volume of urine voided \>3000 mL of urine collected over 24 consecutive hours during the 3-day bladder diary collection period in the Screening phase. * Subject is currently participating in or has previously participated in another therapeutic study within 30 days prior to the start of the Screening phase. * Subject has any condition or situation which, in the investigator's (or subinvestigator's) opinion, puts the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Design outcomes

Primary

Measure	Time frame	Description
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment	Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Secondary

Measure	Time frame	Description
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS2 Population comprised all randomized participants who had at least 1 post-2nd treatment efficacy assessment after 2nd treatment.
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS3 Population comprised of all randomized participants who had at least 1 post-3rd treatment efficacy assessment after 3rd treatment.
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)	Up to 48 weeks in Treatment Cycle 1	A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 Colony Forming Unit per milliliter (CFU/mL) and leukocyturia with \>5 per high power field was noted.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit.
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of Did you have accidental urinary leakage? divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs	Up to 48 weeks in Treatment Cycle 1	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of Did you have accidental urinary leakage? divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of Did you have accidental urinary leakage? divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3	Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Baseline (Pre-dose on Day 1) and Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment	Up to 36 weeks in Treatment Cycle 1	Participants were considered for re-treatment beginning at the Week 12 visit following the initial treatment or the Week 12 visit following any re-treatment. Qualification criteria was; participants must have initiated request for re-treatment, participants experienced \>=2 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, post-void residual (PVR) urine volume must have been \<200 milliliter; investigator deemed re-treatment appropriate. Time to the participant's first qualification for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants fulfilled the qualification for retreatment criteria minus the day of first treatment plus 1.
Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment	Up to 36 weeks in Treatment Cycle 1	The time taken by the participants to request re-treatment was reported. Time to the participant's first request for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants requested retreatment minus the day of first treatment plus 1.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1	KHQ is a 21 item questionnaire, consisting of 9 domains: General health (GH) (1\[Very good\] to 5\[Very poor\]), Incontinence impact (Int Imp) (1\[Not at all\] to 4\[A lot\]), Role Limitations (RL) (1\[Not at all\] to 4\[A lot\]), Physical limitations (PL) (1\[Not at all\] to 4\[A lot\]), Social limitations (SL) (0\[not applicable\] to 4\[A lot\]), Personal relationships (PR) (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), Sleep/ energy (S/ E) (1\[Never\] to 4\[All the time\]) and Severity/Coping (S/ C) (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value,including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2	KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S/ E (1\[Never\] to 4\[All the time\]) and S/ C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3	KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S/ E (1\[Never\] to 4\[All the time\]) and S/ C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1	Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 0, Week 2, Week 6, Week 12, Week 24 and Week 36 in Treatment Cycle 2	Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 0, Week 2, Week 6, Week 12 and Week 24 in Treatment Cycle 3	Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1	Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2	Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3	Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 1 comprised of all participants who received at least one dose of GSK1358820.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 3 comprised of all participants who received at least three doses of GSK1358820.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alkaline Phosphatase (Alk Phosp), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin (Bil), Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein (T Protein), Urea/blood urea nitrogen (BUN) and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils (Eosino), Hemoglobin (Hb), Hematocrit (Hct), Lymphocytes (Lympho), Monocytes, Neutrophil Bands (N bands), Total Neutrophils (T neutro), Platelet count (PC), Red Blood Cell (RBC) count, and White Blood Cell count (WBC). Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Baseline (Pre-dose on Day 1) and up to 48 weeks in Treatment Cycle 1	Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment	Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment	Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment	Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1	The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR	Up to 48 weeks in Treatment Cycle 1	Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound	Up to 48 weeks in Treatment Cycle 1	The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Baseline (Pre-dose on Day 1), Week 12 and Week 48 in Treatment Cycle 1	Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QT interval corrected for heart rate (QTc) value is machine-read or manually over-read. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Countries

Japan

Participant flow

Recruitment details

This study evaluated the efficacy and safety of GSK1358820 (botulinum toxin type A) in participants with overactive bladder. This was a multicenter study conducted in Japan.

Pre-assignment details

A total 354 participants were screened, of which, 104 failed screening and 250 were randomized. Of the 250 randomized, 248 received GSK1358820 100 units (U) or placebo. One participant did not receive treatment due to defective investigational product vial and the other participant was met with protocol exclusion criteria before dosing.

Participants by arm

Arm	Count
Placebo Participants received a single (double-blind) treatment with Placebo (20 injections of 0.5 milliliter \[mL\] each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1. Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment could receive re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.	124
GSK1358820 100 U Participants received a single (double-blind) dose of GSK1358820 (20 injections of 0.5 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1. Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment could receive re-treatment with GSK1358820 100 U (open-label) in Treatment Phase 2 until Week 36 after the first treatment and up to 2 times with an interval of at least 12 weeks between treatments.	124
Total	248

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Double-blinded (Up to 48 Weeks)	Adverse Event	2	1	0	0	0	0
Double-blinded (Up to 48 Weeks)	Investigator discretion	1	0	0	0	0	0
Double-blinded (Up to 48 Weeks)	Protocol Violation	0	3	0	0	0	0
Double-blinded (Up to 48 Weeks)	Reached stopping criteria	1	2	0	0	0	0
Double-blinded (Up to 48 Weeks)	Withdrawal by Subject	1	3	0	0	0	0
Open-label(2nd Treatment-Up to 48 Weeks)	Adverse Event	0	0	1	2	0	0
Open-label(2nd Treatment-Up to 48 Weeks)	Investigator discretion	0	0	1	0	0	0
Open-label(2nd Treatment-Up to 48 Weeks)	Withdrawal by Subject	0	0	7	2	0	0
Open-label(3rd Treatment-Up to 48 Weeks)	Reached stopping criteria	0	0	0	0	2	0
Open-label(3rd Treatment-Up to 48 Weeks)	Withdrawal by Subject	0	0	0	0	0	1

Baseline characteristics

Characteristic	Placebo	GSK1358820 100 U	Total
Age, Continuous	66.2 Years STANDARD_DEVIATION 12.19	65.6 Years STANDARD_DEVIATION 12.43	65.9 Years STANDARD_DEVIATION 12.29
Race/Ethnicity, Customized Asian - Japanese Heritage	124 Participants	124 Participants	248 Participants
Sex: Female, Male Female	94 Participants	92 Participants	186 Participants
Sex: Female, Male Male	30 Participants	32 Participants	62 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 124	0 / 124	0 / 108	0 / 88	0 / 56	0 / 43
other Total, other adverse events	29 / 124	53 / 124	49 / 108	40 / 88	22 / 56	19 / 43
serious Total, serious adverse events	6 / 124	8 / 124	5 / 108	5 / 88	0 / 56	1 / 43

Outcome results

Primary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Time frame: Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1

Population: Full Analysis Set 1(FAS1) Population comprised of all randomized participants who had at least 1 post-Baseline efficacy assessment. Only those participants with data available at specified time point were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment	-1.25 Episodes	Standard Error 0.375
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment	-3.42 Episodes	Standard Error 0.381

p-value: <0.00195% CI: [-3.14, -1.18]MMRM

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Population: FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=124, 120	0.95 Milliliter	Standard Deviation 36.8
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=14, 46	6.39 Milliliter	Standard Deviation 32.508
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=23, 64	5.48 Milliliter	Standard Deviation 31.328
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=122, 122	-1.69 Milliliter	Standard Deviation 34.578
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=12, 32	9.73 Milliliter	Standard Deviation 34.867
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 42; n=11, 27	5.34 Milliliter	Standard Deviation 31.688
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=17, 52	2.37 Milliliter	Standard Deviation 36.827
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 48; n=11, 27	6.60 Milliliter	Standard Deviation 32.58
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=124, 123	3.99 Milliliter	Standard Deviation 29.762
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 48; n=11, 27	14.41 Milliliter	Standard Deviation 42.699
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=124, 123	14.74 Milliliter	Standard Deviation 44.121
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=124, 120	30.19 Milliliter	Standard Deviation 52.077
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=122, 122	29.13 Milliliter	Standard Deviation 46.48
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=23, 64	30.67 Milliliter	Standard Deviation 49.697
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=17, 52	31.67 Milliliter	Standard Deviation 51.061
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=14, 46	32.08 Milliliter	Standard Deviation 57.263
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=12, 32	30.34 Milliliter	Standard Deviation 44.953
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition	Week 42; n=11, 27	17.48 Milliliter	Standard Deviation 38.558

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=122, 122	-0.03 Episodes	Standard Deviation 1.098
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=124, 123	-0.09 Episodes	Standard Deviation 0.835
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=12, 32	0.19 Episodes	Standard Deviation 1.453
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=23, 64	-0.16 Episodes	Standard Deviation 1.247
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=17, 52	0.04 Episodes	Standard Deviation 1.224
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 42; n=11, 27	0.30 Episodes	Standard Deviation 1.574
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=14, 46	0.14 Episodes	Standard Deviation 1.357
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 48; n=11, 27	0.36 Episodes	Standard Deviation 1.487
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=124, 120	-0.13 Episodes	Standard Deviation 1.091
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 48; n=11, 27	-0.19 Episodes	Standard Deviation 0.94
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=124, 120	-0.26 Episodes	Standard Deviation 1.216
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=122, 122	-0.29 Episodes	Standard Deviation 1.447
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=14, 46	-0.15 Episodes	Standard Deviation 0.825
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=12, 32	-0.21 Episodes	Standard Deviation 1.148
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 42; n=11, 27	-0.33 Episodes	Standard Deviation 1.109
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=124, 123	-0.09 Episodes	Standard Deviation 1.275
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=23, 64	-0.53 Episodes	Standard Deviation 1.334
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=17, 52	-0.58 Episodes	Standard Deviation 1.535

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 42; n=11, 27	-1.94 Episodes	Standard Deviation 4.685
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 18; n=23, 64	-1.43 Episodes	Standard Deviation 3.441
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 6; n=124, 120	-1.17 Episodes	Standard Deviation 3.29
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 24; n=17, 52	-2.00 Episodes	Standard Deviation 3.629
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 2; n=124, 123	-0.99 Episodes	Standard Deviation 3.097
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 30; n=14, 46	-2.98 Episodes	Standard Deviation 3.037
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 36; n=12, 32	-2.83 Episodes	Standard Deviation 4.707
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 48; n=11, 27	-1.91 Episodes	Standard Deviation 3.944
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 12; n=122, 122	-0.67 Episodes	Standard Deviation 3.33
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 48; n=11, 27	-2.58 Episodes	Standard Deviation 4.353
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 36; n=12, 32	-3.16 Episodes	Standard Deviation 4.061
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 42; n=11, 27	-3.21 Episodes	Standard Deviation 3.688
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 2; n=124, 123	-2.28 Episodes	Standard Deviation 4.692
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 6; n=124, 120	-3.02 Episodes	Standard Deviation 4.376
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 12; n=122, 122	-2.89 Episodes	Standard Deviation 4.269
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 18; n=23, 64	-3.16 Episodes	Standard Deviation 4.263
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 24; n=17, 52	-3.51 Episodes	Standard Deviation 4.645
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 30; n=14, 46	-3.18 Episodes	Standard Deviation 4.759

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 6; n=124, 120	-0.56 Episodes	Standard Deviation 2.737
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 30; n=14, 46	-1.93 Episodes	Standard Deviation 4.636
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 18; n=23, 64	-0.49 Episodes	Standard Deviation 3.141
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 36; n=12, 32	-1.78 Episodes	Standard Deviation 5.426
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 12; n=122, 122	-0.11 Episodes	Standard Deviation 2.624
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 42; n=11, 27	-0.58 Episodes	Standard Deviation 3.646
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 24; n=17, 52	-1.57 Episodes	Standard Deviation 4.441
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 48; n=11, 27	-1.24 Episodes	Standard Deviation 4.6
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 2; n=124, 123	-0.56 Episodes	Standard Deviation 2.702
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 48; n=11, 27	-1.52 Episodes	Standard Deviation 2.941
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 2; n=124, 123	-1.72 Episodes	Standard Deviation 3.216
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 6; n=124, 120	-1.92 Episodes	Standard Deviation 3.992
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 12; n=122, 122	-1.98 Episodes	Standard Deviation 3.856
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 18; n=23, 64	-2.02 Episodes	Standard Deviation 3.597
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 24; n=17, 52	-1.69 Episodes	Standard Deviation 2.983
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 30; n=14, 46	-1.59 Episodes	Standard Deviation 2.877
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 36; n=12, 32	-1.53 Episodes	Standard Deviation 2.331
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 42; n=11, 27	-1.46 Episodes	Standard Deviation 2.935

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=122, 122	-1.08 Episodes	Standard Deviation 3.809
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=23, 64	-2.46 Episodes	Standard Deviation 3.726
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=14, 46	-3.93 Episodes	Standard Deviation 4.172
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=12, 32	-3.25 Episodes	Standard Deviation 3.921
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=124, 123	-1.10 Episodes	Standard Deviation 3.1
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 42; n=11, 27	-2.88 Episodes	Standard Deviation 4.822
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=17, 52	-3.47 Episodes	Standard Deviation 3.482
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 48; n=11, 27	-2.52 Episodes	Standard Deviation 3.659
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=124, 120	-1.39 Episodes	Standard Deviation 3.607
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 48; n=11, 27	-3.57 Episodes	Standard Deviation 3.943
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=23, 64	-3.99 Episodes	Standard Deviation 4.173
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=17, 52	-4.60 Episodes	Standard Deviation 4.204
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=124, 123	-2.09 Episodes	Standard Deviation 4.826
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=122, 122	-3.39 Episodes	Standard Deviation 4.471
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=14, 46	-3.78 Episodes	Standard Deviation 5.056
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=12, 32	-4.22 Episodes	Standard Deviation 4.514
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 42; n=11, 27	-4.12 Episodes	Standard Deviation 3.586
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=124, 120	-3.30 Episodes	Standard Deviation 4.563

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=124, 123	-0.64 Episodes	Standard Deviation 2.709
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=23, 64	-1.43 Episodes	Standard Deviation 2.587
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 48; n=11, 27	-2.27 Episodes	Standard Deviation 1.965
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=17, 52	-2.43 Episodes	Standard Deviation 1.686
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=124, 120	-0.66 Episodes	Standard Deviation 2.939
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=12, 32	-2.28 Episodes	Standard Deviation 1.65
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=14, 46	-2.50 Episodes	Standard Deviation 1.903
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 42; n=11, 27	-2.36 Episodes	Standard Deviation 1.9
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=122, 122	-0.69 Episodes	Standard Deviation 3.228
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 42; n=11, 27	-3.42 Episodes	Standard Deviation 2.951
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 48; n=11, 27	-3.05 Episodes	Standard Deviation 2.885
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=124, 123	-3.17 Episodes	Standard Deviation 4.182
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=124, 120	-3.44 Episodes	Standard Deviation 4.274
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=122, 122	-3.12 Episodes	Standard Deviation 4.301
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=23, 64	-3.78 Episodes	Standard Deviation 3.272
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=14, 46	-2.99 Episodes	Standard Deviation 3.659
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=12, 32	-3.09 Episodes	Standard Deviation 2.398
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=17, 52	-3.65 Episodes	Standard Deviation 3.22

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 6; n=124, 120	-0.26 Voids	Standard Deviation 2.506
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 30; n=14, 46	-1.29 Voids	Standard Deviation 2.525
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 18; n=23, 64	-1.00 Voids	Standard Deviation 3.338
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 36; n=12, 32	-1.39 Voids	Standard Deviation 2.777
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 12; n=122, 122	-0.41 Voids	Standard Deviation 2.681
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 42; n=11, 27	-1.39 Voids	Standard Deviation 4.044
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 24; n=17, 52	-1.18 Voids	Standard Deviation 2.703
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 48; n=11, 27	-0.36 Voids	Standard Deviation 2.61
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 2; n=124, 123	-0.39 Voids	Standard Deviation 2.419
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 48; n=11, 27	-1.14 Voids	Standard Deviation 2.453
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 2; n=124, 123	-0.71 Voids	Standard Deviation 3.363
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 6; n=124, 120	-1.90 Voids	Standard Deviation 3.418
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 12; n=122, 122	-2.00 Voids	Standard Deviation 3.447
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 18; n=23, 64	-2.46 Voids	Standard Deviation 3.136
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 24; n=17, 52	-2.34 Voids	Standard Deviation 3.334
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 30; n=14, 46	-1.40 Voids	Standard Deviation 2.895
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 36; n=12, 32	-2.06 Voids	Standard Deviation 2.667
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids	Week 42; n=11, 27	-2.06 Voids	Standard Deviation 2.956

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate

Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 6; n=124, 123	-2.7 Beats per minute	Standard Deviation 10.06
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 36; n=12, 32	-5.7 Beats per minute	Standard Deviation 8.58
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 24; n=17, 54	-6.6 Beats per minute	Standard Deviation 13.24
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 42; n=11, 27	2.3 Beats per minute	Standard Deviation 10.69
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 18; n=23, 65	-4.5 Beats per minute	Standard Deviation 10.39
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 48; n=16, 36	-3.8 Beats per minute	Standard Deviation 8.69
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 30; n=14, 47	-5.2 Beats per minute	Standard Deviation 7.68
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 12; n=122, 123	-3.8 Beats per minute	Standard Deviation 9.18
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 2; n=124, 124	-2.2 Beats per minute	Standard Deviation 8.39
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 48; n=16, 36	-3.6 Beats per minute	Standard Deviation 10.06
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 2; n=124, 124	-1.2 Beats per minute	Standard Deviation 10.62
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 12; n=122, 123	-1.6 Beats per minute	Standard Deviation 10.36
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 18; n=23, 65	-3.8 Beats per minute	Standard Deviation 10.11
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 24; n=17, 54	-2.6 Beats per minute	Standard Deviation 10.98
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 30; n=14, 47	-2.7 Beats per minute	Standard Deviation 9.94
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 36; n=12, 32	-3.4 Beats per minute	Standard Deviation 9.64
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 42; n=11, 27	-2.1 Beats per minute	Standard Deviation 9.79
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate	Week 6; n=124, 123	-0.8 Beats per minute	Standard Deviation 10.56

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores

KHQ is a 21 item questionnaire, consisting of 9 domains: General health (GH) (1\[Very good\] to 5\[Very poor\]), Incontinence impact (Int Imp) (1\[Not at all\] to 4\[A lot\]), Role Limitations (RL) (1\[Not at all\] to 4\[A lot\]), Physical limitations (PL) (1\[Not at all\] to 4\[A lot\]), Social limitations (SL) (0\[not applicable\] to 4\[A lot\]), Personal relationships (PR) (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), Sleep/ energy (S/ E) (1\[Never\] to 4\[All the time\]) and Severity/Coping (S/ C) (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value,including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 36;n=12, 32	-22.22 Scores on a scale	Standard Deviation 21.711
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 12;n=121, 123	-0.78 Scores on a scale	Standard Deviation 25.952
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 12;n=122, 123	0.41 Scores on a scale	Standard Deviation 23.223
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 24;n=17, 54	-8.82 Scores on a scale	Standard Deviation 26.43
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 24;n=17, 54	-13.73 Scores on a scale	Standard Deviation 30.752
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 12;n=121, 123	-3.31 Scores on a scale	Standard Deviation 26.581
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 36;n=12, 32	-19.44 Scores on a scale	Standard Deviation 23.391
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 12;n= 121, 123	-3.03 Scores on a scale	Standard Deviation 24.814
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 48;n=11, 27	-16.67 Scores on a scale	Standard Deviation 24.721
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 48;n=11, 27	-20.20 Scores on a scale	Standard Deviation 27.585
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 12;n=122, 123	-2.08 Scores on a scale	Standard Deviation 16.95
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 24;n=17, 54	-13.73 Scores on a scale	Standard Deviation 26.507
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 24;n=17, 54	-9.80 Scores on a scale	Standard Deviation 19.02
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 12;n=91, 79	-3.85 Scores on a scale	Standard Deviation 21.528
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 36;n=12, 32	-23.89 Scores on a scale	Standard Deviation 18.74
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 36;n=12, 32	-18.06 Scores on a scale	Standard Deviation 25.084
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 48;n=11, 27	-18.18 Scores on a scale	Standard Deviation 19.112
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 24;n=13, 35	-10.26 Scores on a scale	Standard Deviation 23.113
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 12;n=122, 123	4.9 Scores on a scale	Standard Deviation 26.43
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 36;n=8, 20	-22.92 Scores on a scale	Standard Deviation 30.78
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 24;n=17, 54	-10.3 Scores on a scale	Standard Deviation 19.88
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 36;n=12, 32	-16.67 Scores on a scale	Standard Deviation 29.302
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 36;n=12, 32	-10.4 Scores on a scale	Standard Deviation 19.82
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 48;n=8, 15	-22.92 Scores on a scale	Standard Deviation 30.78
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 48;n=11, 27	-6.8 Scores on a scale	Standard Deviation 11.68
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 12;n=122, 123	-6.56 Scores on a scale	Standard Deviation 27.32
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 48;n=11, 27	-27.27 Scores on a scale	Standard Deviation 25.025
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 24;n=17, 54	-25.49 Scores on a scale	Standard Deviation 25.082
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 12;n=122, 123	-4.46 Scores on a scale	Standard Deviation 22.841
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 36;n=12, 32	-30.56 Scores on a scale	Standard Deviation 17.164
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 48;n=11, 27	-16.67 Scores on a scale	Standard Deviation 27.889
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 24;n=17, 54	-12.75 Scores on a scale	Standard Deviation 28.175
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 36;n=12, 32	-25.93 Scores on a scale	Standard Deviation 30.089
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 24;n=17, 54	-22.22 Scores on a scale	Standard Deviation 21.155
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 48;n=11, 27	-15.15 Scores on a scale	Standard Deviation 36.098
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 48;n=11, 27	-20.20 Scores on a scale	Standard Deviation 26.675
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 12;n=122, 123	-23.04 Scores on a scale	Standard Deviation 36.497
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 48;n=11, 27	-33.33 Scores on a scale	Standard Deviation 24.46
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 12;n= 121, 123	-18.56 Scores on a scale	Standard Deviation 34.29
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 24;n=17, 54	-30.25 Scores on a scale	Standard Deviation 32.71
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 36;n=12, 32	-26.04 Scores on a scale	Standard Deviation 33.317
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Role Limitations; Week 48;n=11, 27	-22.84 Scores on a scale	Standard Deviation 33.059
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 12;n=121, 123	-15.18 Scores on a scale	Standard Deviation 35.388
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 24;n=17, 54	-27.47 Scores on a scale	Standard Deviation 33.515
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 36;n=12, 32	-24.48 Scores on a scale	Standard Deviation 29.93
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Physical Limitations; Week 48;n=11, 27	-17.28 Scores on a scale	Standard Deviation 32.186
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 12;n=121, 123	-11.92 Scores on a scale	Standard Deviation 30.326
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 24;n=17, 54	-21.60 Scores on a scale	Standard Deviation 34.019
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 36;n=12, 32	-18.23 Scores on a scale	Standard Deviation 33.756
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Social Limitations; Week 48;n=11, 27	-17.70 Scores on a scale	Standard Deviation 27.087
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 12;n=91, 79	-5.06 Scores on a scale	Standard Deviation 23.167
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 36;n=8, 20	-15.00 Scores on a scale	Standard Deviation 28.562
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 48;n=8, 15	-13.33 Scores on a scale	Standard Deviation 23.738
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 12;n=122, 123	-14.63 Scores on a scale	Standard Deviation 28.922
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 24;n=17, 54	-27.98 Scores on a scale	Standard Deviation 30.198
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 48;n=11, 27	-20.58 Scores on a scale	Standard Deviation 28.362
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 12;n=122, 123	-12.74 Scores on a scale	Standard Deviation 25.792
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 24;n=17, 54	-17.28 Scores on a scale	Standard Deviation 26.886
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 36;n=12, 32	-11.98 Scores on a scale	Standard Deviation 27.835
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Sleep/Energy; Week 48;n=11, 27	-9.88 Scores on a scale	Standard Deviation 28.592
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 12;n=122, 123	-11.54 Scores on a scale	Standard Deviation 26.032
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 24;n=17, 54	-18.27 Scores on a scale	Standard Deviation 28.26
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 36;n=12, 32	-14.17 Scores on a scale	Standard Deviation 24.466
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Severity/Coping Measures; Week 48;n=11, 27	-6.67 Scores on a scale	Standard Deviation 26.667
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 12;n=122, 123	-1.8 Scores on a scale	Standard Deviation 24.41
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 24;n=17, 54	-2.8 Scores on a scale	Standard Deviation 17.95
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 36;n=12, 32	-3.9 Scores on a scale	Standard Deviation 18.08
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	General Health Perception; Week 48;n=11, 27	0.0 Scores on a scale	Standard Deviation 19.61
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 24;n=17, 54	-36.42 Scores on a scale	Standard Deviation 32.55
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Incontinence Impact; Week 36;n=12, 32	-43.75 Scores on a scale	Standard Deviation 24.593
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Personal Relationships; Week 24;n=13, 35	-15.24 Scores on a scale	Standard Deviation 30.883
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Emotions; Week 36;n=12, 32	-23.26 Scores on a scale	Standard Deviation 20.616

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume

PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 2; n=124, 123	1.02 Milliliter	Standard Deviation 28.801
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 30; n=14, 47	19.96 Milliliter	Standard Deviation 78.149
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 18; n=23, 65	8.91 Milliliter	Standard Deviation 52.093
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 36; n=12, 32	2.25 Milliliter	Standard Deviation 35.433
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 12; n=122, 123	4.05 Milliliter	Standard Deviation 39.432
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 42; n=11, 27	-15.26 Milliliter	Standard Deviation 42.147
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 24; n=17, 54	2.92 Milliliter	Standard Deviation 37.846
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 48; n=16, 36	10.93 Milliliter	Standard Deviation 69.151
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 6; n=124, 122	1.42 Milliliter	Standard Deviation 36.387
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 48; n=16, 36	5.56 Milliliter	Standard Deviation 35.878
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 2; n=124, 123	44.99 Milliliter	Standard Deviation 76.009
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 6; n=124, 122	25.62 Milliliter	Standard Deviation 50.82
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 12; n=122, 123	16.81 Milliliter	Standard Deviation 35.717
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 18; n=23, 65	16.10 Milliliter	Standard Deviation 42.109
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 24; n=17, 54	18.06 Milliliter	Standard Deviation 45.829
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 30; n=14, 47	13.33 Milliliter	Standard Deviation 39.357
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 36; n=12, 32	9.87 Milliliter	Standard Deviation 36.672
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume	Week 42; n=11, 27	10.83 Milliliter	Standard Deviation 38.952

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 36; n=12, 32	-8.5 Millimeter of mercury	Standard Deviation 18.02
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 24; n=17, 54	-5.0 Millimeter of mercury	Standard Deviation 8.85
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 18; n=23, 65	0.3 Millimeter of mercury	Standard Deviation 19.61
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 30; n=14, 47	-1.4 Millimeter of mercury	Standard Deviation 9.44
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 12; n=122, 123	-2.9 Millimeter of mercury	Standard Deviation 14.05
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 36; n=12, 32	-4.9 Millimeter of mercury	Standard Deviation 7.88
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 2; n=124, 124	0.2 Millimeter of mercury	Standard Deviation 9.39
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 42; n=11, 27	-4.7 Millimeter of mercury	Standard Deviation 10.03
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 24; n=17, 54	-4.8 Millimeter of mercury	Standard Deviation 18.7
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 48; n=16, 36	0.3 Millimeter of mercury	Standard Deviation 6.56
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 6; n=124, 123	-1.6 Millimeter of mercury	Standard Deviation 10.03
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 2; n=124, 124	-0.6 Millimeter of mercury	Standard Deviation 13.24
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 6; n=124, 123	-2.8 Millimeter of mercury	Standard Deviation 13
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 30; n=14, 47	-2.6 Millimeter of mercury	Standard Deviation 23.22
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 42; n=11, 27	-6.1 Millimeter of mercury	Standard Deviation 20.53
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 12; n=122, 123	-1.8 Millimeter of mercury	Standard Deviation 10.89
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 48; n=16, 36	4.5 Millimeter of mercury	Standard Deviation 13.85
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 18; n=23, 65	-1.5 Millimeter of mercury	Standard Deviation 11.61
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 12; n=122, 123	-1.6 Millimeter of mercury	Standard Deviation 10.48
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 6; n=124, 123	-1.1 Millimeter of mercury	Standard Deviation 14.47
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 12; n=122, 123	-1.6 Millimeter of mercury	Standard Deviation 14.42
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 18; n=23, 65	-5.8 Millimeter of mercury	Standard Deviation 14.17
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 30; n=14, 47	-4.6 Millimeter of mercury	Standard Deviation 14.85
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 36; n=12, 32	-5.2 Millimeter of mercury	Standard Deviation 15.94
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 48; n=16, 36	-1.5 Millimeter of mercury	Standard Deviation 16.48
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 2; n=124, 124	-1.4 Millimeter of mercury	Standard Deviation 9.43
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 6; n=124, 123	0.1 Millimeter of mercury	Standard Deviation 10.79
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 18; n=23, 65	-3.0 Millimeter of mercury	Standard Deviation 8.89
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 24; n=17, 54	-3.1 Millimeter of mercury	Standard Deviation 11.46
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 30; n=14, 47	-2.1 Millimeter of mercury	Standard Deviation 10.97
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 36; n=12, 32	-4.3 Millimeter of mercury	Standard Deviation 12.08
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 42; n=11, 27	-4.1 Millimeter of mercury	Standard Deviation 12.05
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP; Week 48; n=16, 36	-2.2 Millimeter of mercury	Standard Deviation 12.79
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 24; n=17, 54	-5.2 Millimeter of mercury	Standard Deviation 14.53
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 42; n=11, 27	-5.8 Millimeter of mercury	Standard Deviation 16.69
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP; Week 2; n=124, 124	-1.5 Millimeter of mercury	Standard Deviation 13.17

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature

Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 2; n=124, 124	-0.04 Degree Celsius	Standard Deviation 0.403
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 6; n=124, 123	-0.03 Degree Celsius	Standard Deviation 0.452
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 12; n=122, 123	-0.13 Degree Celsius	Standard Deviation 0.501
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 36; n=12, 32	-0.11 Degree Celsius	Standard Deviation 0.318
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 42; n=11, 27	-0.10 Degree Celsius	Standard Deviation 0.436
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 48; n=16, 36	0.05 Degree Celsius	Standard Deviation 0.447
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 18; n=23, 65	-0.28 Degree Celsius	Standard Deviation 0.54
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 24; n=17, 54	-0.26 Degree Celsius	Standard Deviation 0.433
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 30; n=14, 47	-0.17 Degree Celsius	Standard Deviation 0.446
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 30; n=14, 47	0.01 Degree Celsius	Standard Deviation 0.45
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 2; n=124, 124	-0.02 Degree Celsius	Standard Deviation 0.46
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 48; n=16, 36	-0.01 Degree Celsius	Standard Deviation 0.467
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 6; n=124, 123	-0.03 Degree Celsius	Standard Deviation 0.497
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 12; n=122, 123	-0.04 Degree Celsius	Standard Deviation 0.47
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 24; n=17, 54	0.06 Degree Celsius	Standard Deviation 0.497
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 36; n=12, 32	-0.03 Degree Celsius	Standard Deviation 0.45
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 18; n=23, 65	-0.01 Degree Celsius	Standard Deviation 0.571
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature	Week 42; n=11, 27	-0.03 Degree Celsius	Standard Deviation 0.525

Secondary

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment

Time frame: Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1

Population: FAS1 Population. Only those participants with data available at specified time point were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment	-0.22 Milliliter	Standard Error 4.329
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment	29.47 Milliliter	Standard Error 4.39

p-value: <0.00195% CI: [18.47, 40.91]MMRM

Secondary

Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=122, 122	-0.92 Episodes	Standard Deviation 3.402
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=23, 64	-1.22 Episodes	Standard Deviation 3.422
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=14, 46	-2.52 Episodes	Standard Deviation 1.92
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 42; n=11, 27	-2.03 Episodes	Standard Deviation 2.079
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 48; n=11, 27	-1.73 Episodes	Standard Deviation 2.732
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=124, 123	-0.84 Episodes	Standard Deviation 2.883
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=124, 120	-0.83 Episodes	Standard Deviation 3.022
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=17, 52	-2.51 Episodes	Standard Deviation 1.704
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=12, 32	-2.03 Episodes	Standard Deviation 2.153
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=12, 32	-3.27 Episodes	Standard Deviation 2.508
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=122, 122	-3.41 Episodes	Standard Deviation 4.394
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=23, 64	-4.07 Episodes	Standard Deviation 3.477
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=124, 123	-3.24 Episodes	Standard Deviation 4.355
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=14, 46	-3.05 Episodes	Standard Deviation 3.826
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=17, 52	-3.88 Episodes	Standard Deviation 3.516
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 42; n=11, 27	-3.42 Episodes	Standard Deviation 3.022
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=124, 120	-3.62 Episodes	Standard Deviation 4.447
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 48; n=11, 27	-3.07 Episodes	Standard Deviation 3.037

Secondary

Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score

Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 12; n=122, 123	-0.7 Scores on a scale	Standard Deviation 2.05
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 24; n=17, 54	-2.7 Scores on a scale	Standard Deviation 2.8
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 36; n=12 ,32	-3.5 Scores on a scale	Standard Deviation 2.02
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 48; n=11, 27	-2.8 Scores on a scale	Standard Deviation 2.68
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 48; n=11, 27	-3.3 Scores on a scale	Standard Deviation 3.02
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 12; n=122, 123	-3.4 Scores on a scale	Standard Deviation 3.5
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 36; n=12 ,32	-3.9 Scores on a scale	Standard Deviation 3.26
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score	Week 24; n=17, 54	-4.4 Scores on a scale	Standard Deviation 3.32

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR

Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks in Treatment Cycle 1

Population: SPDB Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR	7 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QT interval corrected for heart rate (QTc) value is machine-read or manually over-read. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 12; NCS; n=122, 123	28 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 12; CS; n=122, 123	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 48; NCS; n=16, 36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 48; CS; n=16, 36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Baseline; CS; n=124, 124	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Baseline; NCS; n=124, 124	25 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Baseline; CS; n=124, 124	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 12; NCS; n=122, 123	28 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 48; CS; n=16, 36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 12; CS; n=122, 123	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Baseline; NCS; n=124, 124	31 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings	Week 48; NCS; n=16, 36	6 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound

The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.

Time frame: Up to 48 weeks in Treatment Cycle 1

Population: SPDB Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound	Bladder ultrasound	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound	Kidney ultrasound	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound	Kidney ultrasound	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound	Bladder ultrasound	0 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline

Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Population: FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; No change; n=23, 64	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; No change; n=124, 124	89 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point improvement; n=124, 124	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point improvement; n=124, 124	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point improvement; n=124, 124	20 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point improvement; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 2 point improvement; n=124, 124	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point improvement; n=124, 124	24 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point improvement; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point improvement; n=124, 124	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point improvement; n=124, 124	19 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; No change; n=124, 124	95 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; No change; n=124, 124	89 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point improvement; n=23, 64	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point improvement; n=23, 64	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point improvement; n=23, 64	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point improvement; n=17, 52	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point improvement; n=17, 52	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point improvement; n=17, 52	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; No change; n=17, 52	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point improvement; n=14, 46	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point improvement; n=14, 46	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point improvement; n=14, 46	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; No change; n=14, 46	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point improvement; n=12, 32	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point improvement; n=12, 32	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point improvement; n=12, 32	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; No change; n=12, 32	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 3 point improvement; n=11, 27	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 2 point improvement; n=11, 27	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 1 point improvement; n=11, 27	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; No change; n=11, 27	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 3 point improvement; n=11, 27	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 2 point improvement; n=11, 27	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 1 point improvement; n=11, 27	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; No change; n=11, 27	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point worsening; n=124, 124	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point worsening; n=124, 124	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6;2 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point worsening; n=124, 124	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point worsening; n=23, 64	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point worsening; n=23, 64	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point worsening; n=23, 64	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point worsening; n=17, 52	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point worsening; n=17, 52	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point worsening; n=17, 52	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point worsening; n=14, 46	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point worsening; n=14, 46	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point worsening; n=14, 46	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point worsening; n=12, 32	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point worsening; n=12, 32	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point worsening; n=12, 32	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 1 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 2 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 3 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 1 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 2 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 3 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; No change; n=11, 27	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point improvement; n=124, 124	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point worsening; n=23, 64	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 3 point improvement; n=11, 27	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point improvement; n=124, 124	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point worsening; n=12, 32	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 2 point improvement; n=11, 27	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point improvement; n=124, 124	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point worsening; n=17, 52	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 1 point improvement; n=11, 27	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 2 point improvement; n=124, 124	15 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 3 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; No change; n=11, 27	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point worsening; n=17, 52	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point improvement; n=124, 124	13 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point worsening; n=124, 124	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point improvement; n=124, 124	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point worsening; n=12, 32	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point improvement; n=124, 124	31 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; No change; n=124, 124	64 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point improvement; n=124, 124	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; No change; n=124, 124	69 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; No change; n=124, 124	67 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point worsening; n=17, 52	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point improvement; n=23, 64	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point improvement; n=23, 64	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 2 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point improvement; n=23, 64	25 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point improvement; n=124, 124	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; No change; n=23, 64	20 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point worsening; n=124, 124	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point improvement; n=17, 52	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point worsening; n=14, 46	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point improvement; n=17, 52	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6;2 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point improvement; n=17, 52	13 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 1 point worsening; n=11, 27	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; No change; n=17, 52	23 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point improvement; n=14, 46	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point worsening; n=14, 46	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point improvement; n=14, 46	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point worsening; n=124, 124	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point improvement; n=14, 46	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 1 point worsening; n=11, 27	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; No change; n=14, 46	17 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point improvement; n=12, 32	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point worsening; n=14, 46	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point improvement; n=12, 32	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point worsening; n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point improvement; n=12, 32	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 2 point worsening; n=11, 27	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; No change; n=12, 32	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point worsening; n=23, 64	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 3 point improvement; n=11, 27	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point worsening; n=12, 32	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 2 point improvement; n=11, 27	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point worsening; n=23, 64	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 42; 1 point improvement; n=11, 27	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 48; 3 point worsening; n=11, 27	0 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity

The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Population: FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 18; n=23, 64	12 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 2; n=124, 124	25 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 24; n=17, 52	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 18; n=23, 64	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 24; n=17, 52	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 2; n=124, 124	87 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 24; n=17, 52	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 6; n=124, 124	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 24; n=17, 52	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Baseline (Pre-dose, Day 1); n=124, 124	24 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 30; n=14, 46	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 6; n=124, 124	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 30; n=14, 46	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 2; n=124, 124	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 30; n=14, 46	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 6; n=124, 124	23 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 36; n=12, 32	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 6; n=124, 124	86 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 36; n=12, 32	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 30; n=14, 46	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 36; n=12, 32	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Baseline (Pre-dose, Day 1); n=124, 124	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 36; n=12, 32	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 12; n=124, 124	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 42; n=11, 27	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 12; n=124, 124	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 42; n=11, 27	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 2; n=124, 124	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 42; n=11, 27	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 12; n=124, 124	22 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 42; n=11, 27	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 12; n=124, 124	90 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 48; n=11, 27	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 18; n=23, 64	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 48; n=11, 27	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Baseline (Pre-dose, Day 1); n=124, 124	99 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 48; n=11, 27	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 18; n=23, 64	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 48; n=11, 27	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Baseline (Pre-dose, Day 1); n=124, 124	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 48; n=11, 27	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Baseline (Pre-dose, Day 1); n=124, 124	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Baseline (Pre-dose, Day 1); n=124, 124	105 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 2; n=124, 124	21 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 2; n=124, 124	61 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 6; n=124, 124	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 12; n=124, 124	37 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 18; n=23, 64	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 18; n=23, 64	19 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 30; n=14, 46	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Baseline (Pre-dose, Day 1); n=124, 124	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Baseline (Pre-dose, Day 1); n=124, 124	16 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 2; n=124, 124	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 2; n=124, 124	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 6; n=124, 124	15 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 6; n=124, 124	20 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 6; n=124, 124	57 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 12; n=124, 124	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 12; n=124, 124	16 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 12; n=124, 124	63 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 18; n=23, 64	11 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 18; n=23, 64	22 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 24; n=17, 52	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 24; n=17, 52	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 24; n=17, 52	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 24; n=17, 52	20 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 30; n=14, 46	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 30; n=14, 46	13 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 30; n=14, 46	16 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 36; n=12, 32	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 36; n=12, 32	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 36; n=12, 32	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 36; n=12, 32	11 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 42; n=11, 27	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 42; n=11, 27	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 42; n=11, 27	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Severe; Week 42; n=11, 27	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	None; Week 48; n=11, 27	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Mild; Week 48; n=11, 27	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity	Moderate; Week 48; n=11, 27	9 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.

Time frame: Up to 48 weeks in Treatment Cycle 1

Population: Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs	Any non-SAE	29 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs	Any SAE	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs	Any non-SAE	53 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs	Any SAE	8 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results

Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alkaline Phosphatase (Alk Phosp), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin (Bil), Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein (T Protein), Urea/blood urea nitrogen (BUN) and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To High; n=122, 122	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST;To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To Normal or No Change; n=122, 122	122 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Normal or No Change; n=122, 121	117 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Low; n=16,35	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Normal or No Change; n=16,35	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Normal or No Change; n=122,122	121 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Low; n=122, 123	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Normal or No Change; n=122, 123	101 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To High; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To Low; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium;To Normal or No Change; n=122,122	121 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To Low; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To Low; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To Normal or No Change; n=122, 122	122 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To Low; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid;To Normal or No Change;n=122, 122	116 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To High; n=122, 122	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid;To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 12:Albumin; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 48:Albumin; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To Low; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp;To Normal or No Change;n=122,122	116 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To High; n= 122 ,122	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp;To Normal or No Change;n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To High; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Low; n= 122 ,122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Normal or No Change; n=122, 122	120 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT; To High; n=122, 122	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST;To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil;To Normal or No Change;n=122,122	122 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil;To Normal or NoChange; n=122,122	120 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To High; n=122, 122	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Low; n=122, 121	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To High; n=122, 121	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To High; n=16,35	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To High; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To Low; n=122, 122	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine;To Normal or NoChange; n=122,122	114 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To High; n=122, 122	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To High; n=122, 123	20 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Normal or No Change; n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Low; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Normal or No Change; n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium;To Normal or No Change; n=122, 122	122 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium;To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To Low; n=122, 122	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12: T Protein;To Normal or No Change;n=122,122	108 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein;To Normal or No Change; n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12Urea/BUN; To Normal or No Change; n=122, 122	119 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST;To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To Normal or No Change; n=122, 122	121 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To High; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 48:Albumin; To Low; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To Low; n=122, 122	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid;To Normal or No Change; n=16,36	34 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To Normal or No Change; n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST;To Low; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To High; n=122, 123	17 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To Low; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To High; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To High; n=122, 121	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil;To Normal or No Change;n=122,122	122 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Normal or No Change; n=16,35	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To High; n=16,35	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Low; n=122, 122	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To High; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Normal or No Change; n=122,122	119 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To High; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To High; n=16,36	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Normal or No Change; n=16,36	34 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To Low; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To High; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To Low; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Normal or No Change; n=16,36	31 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium;To Normal or No Change; n=122,122	118 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To Low; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To Low; n=122, 122	14 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To High; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To High; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil;To Normal or NoChange; n=122,122	121 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To High; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Normal or No Change; n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To Low; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12Urea/BUN; To Normal or No Change; n=122, 122	116 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To High; n=122, 122	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12: T Protein;To Normal or No Change;n=122,122	108 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Low; n=122, 121	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To Low; n=122, 122	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Normal or No Change; n=122, 121	117 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid;To Normal or No Change;n=122, 122	117 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To High; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Low; n=16,35	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 12:Albumin; To Low; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To Low; n=16,36	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To Low; n=122, 122	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To Normal or No Change; n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Low; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To Low; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp;To Normal or No Change;n=122,122	117 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium;To Normal or No Change; n=122, 122	116 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To High; n= 122 ,122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To Low; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein;To Normal or No Change; n=16,36	31 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp;To Normal or No Change;n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine;To Normal or NoChange; n=122,122	116 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To Low; n=16,36	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Low; n= 122 ,122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Normal or No Change; n=122, 122	117 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT; To High; n=122, 122	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium;To Normal or No Change; n=16,36	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To Normal or No Change; n=122, 122	119 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Low; n=122, 123	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To High; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Normal or No Change; n=122, 123	106 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils (Eosino), Hemoglobin (Hb), Hematocrit (Hct), Lymphocytes (Lympho), Monocytes, Neutrophil Bands (N bands), Total Neutrophils (T neutro), Platelet count (PC), Red Blood Cell (RBC) count, and White Blood Cell count (WBC). Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb; To High; n=122, 123	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hb; To Normal or No Change; n=122, 123	116 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Monocytes; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Normal or No Change;n=122,122	122 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Normal or No Change;n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino;To Normal or No Change;n=122,122	120 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Eosino; To High; n=122, 122	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino;To Normal or No Change;n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Eosino; To High; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb;To Low;n=122, 123	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb;To Low;n=16,36	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hb; To Normal or No Change; n=16,36	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To Low; n=122, 123	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hct;To Normal or No Change; n=122, 123	119 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To High; n=122, 123	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hct;To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To Low; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Lympho; To Normal or No Change; n=122, 122	121 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To High; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Lympho; To Normal or No Change; n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To Low; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Monocytes;To Normal or No Change;n=122,122	120 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To High; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes;To Normal or No Change;n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:N bands; To Low; n=122, 122	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands;To Normal or No Change;n=122,122	119 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands; To High; n=122, 122	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:N bands; To Low; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands;To Normal or No Change;n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To Low; n=122, 122	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro;To Normal or No Change;n=122,122	120 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To High; n=122, 122	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To Low; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro;To Normal or No Change;n=16,36	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To High; n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:PC; To Low; n=122, 123	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:PC; To Normal or No Change; n=122, 123	116 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: PC; To High;n=122, 123	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:PC; To Low; n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:PC; To Normal or No Change; n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: PC; To High;n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count; To Low;n=122, 123	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To Normal or No Change;n=122,123	114 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To High;n=122, 123	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count; To Low;n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To Normal or No Change;n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To High;n=16,36	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To Low;n=122, 123	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count;To Normal or No Change;n=122,123	120 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To High; n=122,123	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To Low;n=16,36	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count;To Normal or No Change;n=16,36	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hct;To Normal or No Change; n=122, 123	117 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To High; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:PC; To Normal or No Change; n=122, 123	118 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes;To Normal or No Change;n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Monocytes; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:PC; To Normal or No Change; n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Low; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Normal or No Change;n=122,122	122 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils; To High; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: PC; To High;n=122, 123	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:N bands; To Low; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Normal or No Change;n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To Normal or No Change;n=16,36	34 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands;To Normal or No Change;n=122,122	120 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino; To Low; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:PC; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino;To Normal or No Change;n=122,122	120 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands; To High; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Eosino; To High; n=122, 122	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To High; n=122,123	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:N bands; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino;To Normal or No Change;n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To High;n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Eosino; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands;To Normal or No Change;n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb;To Low;n=122, 123	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hb; To Normal or No Change; n=122, 123	117 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: PC; To High;n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb; To High; n=122, 123	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands; To High; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb;To Low;n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count;To Normal or No Change;n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hb; To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To Low; n=122, 122	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count; To Low;n=122, 123	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To Low; n=122, 123	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro;To Normal or No Change;n=122,122	118 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To Low;n=122, 123	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To High; n=122, 123	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To High; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hct;To Normal or No Change; n=16,36	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To Normal or No Change;n=122,123	114 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To Low; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To Low; n=122, 122	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To Low;n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Lympho; To Normal or No Change; n=122, 122	115 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro;To Normal or No Change;n=16,36	33 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To High; n=122, 122	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To High;n=122, 123	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To Low; n=16,36	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To High; n=16,36	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Lympho; To Normal or No Change; n=16,36	35 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count;To Normal or No Change;n=122,123	116 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To High; n=16,36	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:PC; To Low; n=122, 123	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To Low; n=122, 122	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count; To Low;n=16,36	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Monocytes;To Normal or No Change;n=122,122	122 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 Colony Forming Unit per milliliter (CFU/mL) and leukocyturia with \>5 per high power field was noted.

Time frame: Up to 48 weeks in Treatment Cycle 1

Population: SPDB Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)	22 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline

Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame: Baseline (Pre-dose on Day 1) and up to 48 weeks in Treatment Cycle 1

Population: SPDB Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Any Increase	26 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 2+	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 3+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; No Change/Decreased	98 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to Traces	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 1+	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 4+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; No Change/Decreased	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Any Increase	19 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to Traces	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 1+	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 2+	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 3+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 1+	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; No Change/Decreased	111 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 3+	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Any Increase	13 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; No Change/Decreased	92 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Any Increase	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 2+	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to Traces	11 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to Traces	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 1+	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 2+	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 3+	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 4+	0 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=124, 120	3.10 Percent change	Standard Deviation 28.671
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=14, 46	9.87 Percent change	Standard Deviation 31.384
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=122, 122	1.93 Percent change	Standard Deviation 29.197
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=12, 32	8.51 Percent change	Standard Deviation 24.109
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=124, 123	4.47 Percent change	Standard Deviation 24.306
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 42; n=11, 27	8.41 Percent change	Standard Deviation 32.804
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=23, 64	7.61 Percent change	Standard Deviation 27.947
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 48; n=11, 27	9.11 Percent change	Standard Deviation 28.104
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=17, 52	6.94 Percent change	Standard Deviation 32.66
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 48; n=11, 27	11.98 Percent change	Standard Deviation 36.358
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=23, 64	28.64 Percent change	Standard Deviation 48.898
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=124, 123	14.47 Percent change	Standard Deviation 35.109
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=122, 122	27.42 Percent change	Standard Deviation 41.44
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=17, 52	26.80 Percent change	Standard Deviation 45.728
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=14, 46	24.39 Percent change	Standard Deviation 36.838
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=12, 32	26.08 Percent change	Standard Deviation 41.728
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 42; n=11, 27	14.91 Percent change	Standard Deviation 32.231
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=124, 120	28.73 Percent change	Standard Deviation 43.846

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 48; n=11, 27	-35.81 Percent change	Standard Deviation 56.08
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=17, 52	-44.53 Percent change	Standard Deviation 46.229
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=122, 122	-6.15 Percent change	Standard Deviation 55.275
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=14, 46	-45.85 Percent change	Standard Deviation 49.841
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=23, 64	-24.56 Percent change	Standard Deviation 67.816
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=12, 32	-41.35 Percent change	Standard Deviation 47.808
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=124, 120	-13.36 Percent change	Standard Deviation 39.284
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 42; n=11, 27	-36.82 Percent change	Standard Deviation 73.233
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=124, 123	-11.62 Percent change	Standard Deviation 36.556
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 42; n=11, 27	-51.54 Percent change	Standard Deviation 44.338
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=124, 120	-29.25 Percent change	Standard Deviation 99.826
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=122, 122	-28.92 Percent change	Standard Deviation 76.618
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 48; n=11, 27	-47.94 Percent change	Standard Deviation 52.2
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=124, 123	-12.27 Percent change	Standard Deviation 139.897
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=23, 64	-41.72 Percent change	Standard Deviation 54.362
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=17, 52	-54.05 Percent change	Standard Deviation 45.299
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=14, 46	-39.11 Percent change	Standard Deviation 59.666
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=12, 32	-49.87 Percent change	Standard Deviation 52.601

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=124, 123	-12.68 Percent change	Standard Deviation 45.315
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=124, 120	-7.97 Percent change	Standard Deviation 74.45
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=122, 122	-8.82 Percent change	Standard Deviation 61.933
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=23, 64	-13.19 Percent change	Standard Deviation 140.232
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=17, 52	-58.96 Percent change	Standard Deviation 46.668
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=14, 46	-64.58 Percent change	Standard Deviation 47.877
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=12, 32	-61.62 Percent change	Standard Deviation 44.722
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 42; n=11, 27	-48.59 Percent change	Standard Deviation 62.571
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 48; n=11, 27	-34.51 Percent change	Standard Deviation 91.409
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=12, 32	-62.82 Percent change	Standard Deviation 39.971
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=124, 123	-33.38 Percent change	Standard Deviation 202.484
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 48; n=11, 27	-63.06 Percent change	Standard Deviation 36.96
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=124, 120	-38.84 Percent change	Standard Deviation 201.345
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=122, 122	-38.27 Percent change	Standard Deviation 146.283
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=17, 52	-69.46 Percent change	Standard Deviation 38.644
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=14, 46	-47.52 Percent change	Standard Deviation 60.743
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 42; n=11, 27	-63.46 Percent change	Standard Deviation 46.638
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=23, 64	-64.41 Percent change	Standard Deviation 37.98

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=124, 120	-7.81 Percent change	Standard Deviation 75.815
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=17, 52	-60.58 Percent change	Standard Deviation 47.367
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=12, 32	-66.48 Percent change	Standard Deviation 33.584
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=124, 123	-12.65 Percent change	Standard Deviation 47.51
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=122, 122	-5.35 Percent change	Standard Deviation 67.599
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=23, 64	-30.32 Percent change	Standard Deviation 71.194
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=14, 46	-67.17 Percent change	Standard Deviation 48.289
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 42; n=11, 27	-57.05 Percent change	Standard Deviation 59.914
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 48; n=11, 27	-58.83 Percent change	Standard Deviation 69.302
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 48; n=11, 27	-69.56 Percent change	Standard Deviation 35.673
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=124, 120	-40.56 Percent change	Standard Deviation 193.346
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=23, 64	-66.24 Percent change	Standard Deviation 37.732
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=17, 52	-72.58 Percent change	Standard Deviation 36.701
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 42; n=11, 27	-72.13 Percent change	Standard Deviation 45.202
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=14, 46	-50.68 Percent change	Standard Deviation 60.176
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=124, 123	-34.86 Percent change	Standard Deviation 202.832
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=12, 32	-64.98 Percent change	Standard Deviation 41.02
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=122, 122	-36.86 Percent change	Standard Deviation 143.314

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 2; n=124, 123	-1.65 Percent change	Standard Deviation 19.992
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 36; n=12, 32	-8.33 Percent change	Standard Deviation 15.374
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 42; n=11, 27	-14.26 Percent change	Standard Deviation 38.087
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 6; n=124, 120	-1.05 Percent change	Standard Deviation 20.639
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 12; n=122, 122	-2.59 Percent change	Standard Deviation 21.271
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 18; n=23, 64	-4.81 Percent change	Standard Deviation 24.135
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 24; n=17, 52	-6.21 Percent change	Standard Deviation 18.99
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 30; n=14, 46	-8.36 Percent change	Standard Deviation 15.789
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 48; n=11, 27	-2.50 Percent change	Standard Deviation 18.16
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 6; n=124, 120	-12.81 Percent change	Standard Deviation 25.192
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 2; n=124, 123	-4.31 Percent change	Standard Deviation 27.295
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 18; n=23, 64	-18.70 Percent change	Standard Deviation 20.675
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 30; n=14, 46	-10.35 Percent change	Standard Deviation 21.713
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 36; n=12, 32	-16.22 Percent change	Standard Deviation 21.705
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 12; n=122, 122	-14.12 Percent change	Standard Deviation 25.463
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 42; n=11, 27	-15.40 Percent change	Standard Deviation 22.368
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 48; n=11, 27	-7.82 Percent change	Standard Deviation 22.261
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids	Week 24; n=17, 52	-18.29 Percent change	Standard Deviation 21.921

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=112, 102	-7.29 Percent change	Standard Deviation 65.866
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=15, 41	18.51 Percent change	Standard Deviation 141.097
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=111, 103	7.83 Percent change	Standard Deviation 79.745
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=11, 37	-3.25 Percent change	Standard Deviation 142.123
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 42; n=9, 22	29.63 Percent change	Standard Deviation 224.354
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=10, 26	35.52 Percent change	Standard Deviation 206.821
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=20, 50	5.01 Percent change	Standard Deviation 142.476
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 48; n=9, 22	38.52 Percent change	Standard Deviation 189.877
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=112, 104	-2.92 Percent change	Standard Deviation 78.249
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 48; n=9, 22	-9.60 Percent change	Standard Deviation 78.016
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=112, 104	-0.87 Percent change	Standard Deviation 92.501
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=112, 102	-7.81 Percent change	Standard Deviation 86.301
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 42; n=9, 22	-15.72 Percent change	Standard Deviation 94.273
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=111, 103	-7.23 Percent change	Standard Deviation 114.564
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=20, 50	-29.88 Percent change	Standard Deviation 58.668
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=15, 41	-21.27 Percent change	Standard Deviation 97.052
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=11, 37	-0.22 Percent change	Standard Deviation 80.388
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=10, 26	-8.10 Percent change	Standard Deviation 89.63

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Population: FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; 100 %; n=124, 124	3 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=75%; n=124, 124	10 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; 100 %; n=124, 124	4 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=50%; n=124, 124	27 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; 100 %; n=124, 124	5 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=75%; n=124, 124	13 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=50%; n=124, 124	26 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=75%; n= 23, 64	35 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=50%; n=23, 64	52 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; 100 %; n= 17, 52	29 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=75%; n=17, 52	53 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=50%; n=17, 52	76 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; 100 %; n=14, 46	43 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=75%; n=14, 46	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=50%; n=14, 46	71 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; 100 %; n=12, 32	25 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=75%; n=12, 32	58 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=50%; n=12, 32	75 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 42; 100 %; n= 11, 27	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 42; >=75%; n=11, 27	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 42; >=50%; n=11, 27	73 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 48; 100 %; n= 11, 27	36 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 48; >=75%; n=11, 27	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 48; >=50%; n=11, 27	82 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=50%; n=124, 124	25 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=75%; n=124, 124	9 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; 100 %; n=23, 64	13 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 48; >=75%; n=11, 27	56 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; 100 %; n=124, 124	19 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=50%; n=14, 46	70 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=75%; n=124, 124	44 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=50%; n=124, 124	56 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=75%; n= 23, 64	56 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; 100 %; n=124, 124	30 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=75%; n=124, 124	44 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 48; >=50%; n=11, 27	78 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=50%; n=124, 124	61 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=75%; n=12, 32	53 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; 100 %; n=124, 124	21 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 42; >=75%; n=11, 27	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=75%; n=124, 124	42 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=50%; n=12, 32	72 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=50%; n=23, 64	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; 100 %; n=12, 32	38 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=50%; n=124, 124	58 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; 100 %; n= 17, 52	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 42; >=50%; n=11, 27	81 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=75%; n=17, 52	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 42; 100 %; n= 11, 27	44 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=50%; n=17, 52	81 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 48; 100 %; n= 11, 27	37 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; 100 %; n=14, 46	30 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; 100 %; n=23, 64	36 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=75%; n=14, 46	54 Percentage of participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1

Population: FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=50%; n=17, 52	71 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; 100 %; n=14, 46	36 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=75%; n=124, 124	8 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=75%; n=14, 46	57 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=50%; n=124, 124	24 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=50%; n=14, 46	71 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=75%; n=124, 124	9 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; 100 %; n=12, 32	25 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; 100 %; n=23, 64	13 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=75%; n=12, 32	58 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=50%; n=124, 124	27 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=50%; n=12, 32	75 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=75%; n= 23, 64	35 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 42; 100 %; n= 11, 27	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; 100 %; n=124, 124	3 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 42; >=75%; n=11, 27	55 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=50%; n=23, 64	52 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 42; >=50%; n=11, 27	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; 100 %; n=124, 124	3 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 48; 100 %; n= 11, 27	27 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; 100 %; n= 17, 52	24 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 48; >=75%; n=11, 27	55 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=50%; n=124, 124	23 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 48; >=50%; n=11, 27	73 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=75%; n=17, 52	53 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=75%; n=124, 124	14 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; 100 %; n=124, 124	3 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 48; 100 %; n= 11, 27	33 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=75%; n=124, 124	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=50%; n=124, 124	55 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; 100 %; n=124, 124	27 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=75%; n=124, 124	41 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=50%; n=124, 124	60 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; 100 %; n=124, 124	19 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=75%; n=124, 124	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=50%; n=124, 124	58 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; 100 %; n=23, 64	33 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=75%; n= 23, 64	56 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=50%; n=23, 64	66 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; 100 %; n= 17, 52	38 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=75%; n=17, 52	63 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; 100 %; n=14, 46	28 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=75%; n=14, 46	52 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=50%; n=14, 46	65 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; 100 %; n=12, 32	34 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=75%; n=12, 32	50 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=50%; n=12, 32	66 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 42; 100 %; n= 11, 27	33 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 42; >=75%; n=11, 27	56 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 42; >=50%; n=11, 27	70 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; 100 %; n=124, 124	18 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 48; >=75%; n=11, 27	48 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=50%; n=17, 52	77 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 48; >=50%; n=11, 27	63 Percentage of participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)

Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').

Time frame: Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

Population: FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 2; n=124 ,124	22 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 6; n=124 ,124	23 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 12; n=124 ,124	17 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 24; n=17, 54	53 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 36; n=12, 32	67 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 48; n=11, 27	45 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 36; n=12, 32	69 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 2; n=124 ,124	60 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 24; n=17, 54	69 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 6; n=124 ,124	64 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 48; n=11, 27	70 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)	Week 12; n=124 ,124	57 Percentage of participants

Secondary

Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment

Participants were considered for re-treatment beginning at the Week 12 visit following the initial treatment or the Week 12 visit following any re-treatment. Qualification criteria was; participants must have initiated request for re-treatment, participants experienced \>=2 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, post-void residual (PVR) urine volume must have been \<200 milliliter; investigator deemed re-treatment appropriate. Time to the participant's first qualification for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants fulfilled the qualification for retreatment criteria minus the day of first treatment plus 1.

Time frame: Up to 36 weeks in Treatment Cycle 1

Population: FAS1 Population.

Arm	Measure	Value (MEDIAN)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment	85.0 Days
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment	127.0 Days

p-value: <0.00195% CI: [0.34, 0.6]Log Rank

Secondary

Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment

The time taken by the participants to request re-treatment was reported. Time to the participant's first request for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants requested retreatment minus the day of first treatment plus 1.

Time frame: Up to 36 weeks in Treatment Cycle 1

Population: FAS1 Population.

Arm	Measure	Value (MEDIAN)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment	85.0 Days
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment	92.0 Days

p-value: <0.00195% CI: [0.38, 0.66]Log Rank

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=83,46	28.53 Milliliter	Standard Deviation 43.876
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=108,88	-2.10 Milliliter	Standard Deviation 34.115
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=103,87	17.38 Milliliter	Standard Deviation 44.216
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=36,15	38.27 Milliliter	Standard Deviation 57.547
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=106,84	25.80 Milliliter	Standard Deviation 50.63
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=45,20	28.88 Milliliter	Standard Deviation 50.296
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=106,85	26.72 Milliliter	Standard Deviation 49.861
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=20,6	43.99 Milliliter	Standard Deviation 63.155
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=83,46	12.34 Milliliter	Standard Deviation 50.453
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=106,85	24.04 Milliliter	Standard Deviation 51.918
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=45,20	22.34 Milliliter	Standard Deviation 39.877
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=36,15	26.74 Milliliter	Standard Deviation 45.696
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=20,6	9.49 Milliliter	Standard Deviation 69.972
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=103,87	20.44 Milliliter	Standard Deviation 51.406
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=106,84	29.03 Milliliter	Standard Deviation 56.182
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=108,88	25.74 Milliliter	Standard Deviation 45.213

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=106,85	-0.36 Episodes	Standard Deviation 1.266
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=106,84	-0.45 Episodes	Standard Deviation 1.079
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=83,46	-0.33 Episodes	Standard Deviation 1.032
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=36,15	-0.01 Episodes	Standard Deviation 0.964
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=45,21	-0.24 Episodes	Standard Deviation 0.831
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=108,88	-0.10 Episodes	Standard Deviation 1.079
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=20,6	0.05 Episodes	Standard Deviation 0.987
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=105,87	-0.32 Episodes	Standard Deviation 1.02
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=20,6	0.61 Episodes	Standard Deviation 1.769
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=106,84	-0.45 Episodes	Standard Deviation 1.358
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=106,85	-0.38 Episodes	Standard Deviation 1.331
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=45,21	-0.03 Episodes	Standard Deviation 0.888
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=105,87	-0.42 Episodes	Standard Deviation 1.309
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=83,46	-0.40 Episodes	Standard Deviation 1.49
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=36,15	0.02 Episodes	Standard Deviation 0.831
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=108,88	-0.32 Episodes	Standard Deviation 1.303

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 0; n=108,88	-0.40 Episodes	Standard Deviation 3.3
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 24; n=45,21	-3.33 Episodes	Standard Deviation 3.98
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 2; n=105,87	-3.35 Episodes	Standard Deviation 3.819
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 6; n=106,84	-3.19 Episodes	Standard Deviation 4.063
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 12; n=106,85	-3.10 Episodes	Standard Deviation 3.785
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 18; n=83,46	-3.03 Episodes	Standard Deviation 3.626
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 30; n=36,15	-2.73 Episodes	Standard Deviation 5.063
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 36; n=20,6	-4.12 Episodes	Standard Deviation 4.747
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 6; n=106,84	-3.34 Episodes	Standard Deviation 3.89
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 18; n=83,46	-2.76 Episodes	Standard Deviation 4.202
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 24; n=45,21	-3.44 Episodes	Standard Deviation 3.015
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 36; n=20,6	-1.22 Episodes	Standard Deviation 4.698
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 0; n=108,88	-2.71 Episodes	Standard Deviation 3.874
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 12; n=106,85	-3.29 Episodes	Standard Deviation 3.663
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 2; n=105,87	-3.39 Episodes	Standard Deviation 4.467
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 30; n=36,15	-3.62 Episodes	Standard Deviation 3.354

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 0; n=108,88	-0.00 Episodes	Standard Deviation 2.698
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 30; n=36,15	-1.56 Episodes	Standard Deviation 3.412
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 36; n=20,6	-2.03 Episodes	Standard Deviation 3.707
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 2; n=105,87	-2.11 Episodes	Standard Deviation 2.822
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 6; n=106,84	-1.89 Episodes	Standard Deviation 2.85
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 12; n=106,85	-1.69 Episodes	Standard Deviation 2.952
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 18; n=83,46	-1.58 Episodes	Standard Deviation 3.171
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 24; n=45,21	-1.78 Episodes	Standard Deviation 3.194
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 2; n=105,87	-2.26 Episodes	Standard Deviation 4.424
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 0; n=108,88	-1.90 Episodes	Standard Deviation 3.799
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 24; n=45,21	-3.00 Episodes	Standard Deviation 4.603
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 12; n=106,85	-2.52 Episodes	Standard Deviation 4.031
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 30; n=36,15	-3.27 Episodes	Standard Deviation 4.823
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 6; n=106,84	-2.37 Episodes	Standard Deviation 3.952
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 36; n=20,6	-1.00 Episodes	Standard Deviation 3.502
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 18; n=83,46	-1.92 Episodes	Standard Deviation 3.794

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=83,46	-3.86 Episodes	Standard Deviation 3.972
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=45,21	-4.47 Episodes	Standard Deviation 4.352
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=36,15	-4.06 Episodes	Standard Deviation 5.02
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=20,6	-5.08 Episodes	Standard Deviation 5.582
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=108,88	-0.79 Episodes	Standard Deviation 3.639
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=105,87	-3.63 Episodes	Standard Deviation 4.58
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=106,84	-4.28 Episodes	Standard Deviation 4.074
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=106,85	-4.10 Episodes	Standard Deviation 4.118
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=106,85	-3.67 Episodes	Standard Deviation 3.591
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=83,46	-3.06 Episodes	Standard Deviation 3.699
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=108,88	-2.42 Episodes	Standard Deviation 3.822
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=45,21	-3.49 Episodes	Standard Deviation 2.662
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=106,84	-3.83 Episodes	Standard Deviation 3.962
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=36,15	-3.42 Episodes	Standard Deviation 2.435
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=105,87	-3.69 Episodes	Standard Deviation 4.347
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=20,6	-1.72 Episodes	Standard Deviation 4.716

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=108,88	-0.36 Episodes	Standard Deviation 3.326
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=106,84	-3.67 Episodes	Standard Deviation 3.301
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=83,46	-3.45 Episodes	Standard Deviation 3.238
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=45,21	-3.59 Episodes	Standard Deviation 3.72
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=20,6	-4.37 Episodes	Standard Deviation 3.169
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=105,87	-4.01 Episodes	Standard Deviation 3.529
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=106,85	-3.46 Episodes	Standard Deviation 3.556
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=36,15	-3.65 Episodes	Standard Deviation 3.728
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=20,6	-2.78 Episodes	Standard Deviation 3.06
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=105,87	-4.41 Episodes	Standard Deviation 3.56
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=108,88	-2.65 Episodes	Standard Deviation 4.075
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=106,85	-4.24 Episodes	Standard Deviation 4.094
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=83,46	-3.88 Episodes	Standard Deviation 3.64
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=106,84	-4.21 Episodes	Standard Deviation 3.733
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=36,15	-4.56 Episodes	Standard Deviation 3.945
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=45,21	-4.84 Episodes	Standard Deviation 3.359

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 24; n=45,21	-2.62 Voids	Standard Deviation 2.169
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 2; n=105,87	-1.58 Voids	Standard Deviation 3.473
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 18; n=83,46	-2.41 Voids	Standard Deviation 2.312
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 12; n=106,85	-2.22 Voids	Standard Deviation 3.164
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 30; n=36,15	-2.48 Voids	Standard Deviation 3.051
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 0; n=108,88	-0.16 Voids	Standard Deviation 2.579
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 36; n=20,6	-2.73 Voids	Standard Deviation 3.037
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 6; n=106,84	-2.04 Voids	Standard Deviation 3.199
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 36; n=20,6	-0.39 Voids	Standard Deviation 3.044
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 6; n=106,84	-2.21 Voids	Standard Deviation 2.879
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 12; n=106,85	-1.99 Voids	Standard Deviation 2.575
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 18; n=83,46	-1.53 Voids	Standard Deviation 2.789
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 24; n=45,21	-2.59 Voids	Standard Deviation 2.738
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 0; n=108,88	-1.46 Voids	Standard Deviation 2.556
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 2; n=105,87	-1.68 Voids	Standard Deviation 3.394
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids	Week 30; n=36,15	-2.49 Voids	Standard Deviation 2.597

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 12; n=85	-1.8 Beats per minute	Standard Deviation 11.01
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 18; n=39	-0.0 Beats per minute	Standard Deviation 10.35
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 24; n=19	0.3 Beats per minute	Standard Deviation 9.67
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 30; n=14	2.7 Beats per minute	Standard Deviation 9.24
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 48; n=45	1.0 Beats per minute	Standard Deviation 9.17
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 0; n=87	1.9 Beats per minute	Standard Deviation 9.75
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 2; n=87	0.6 Beats per minute	Standard Deviation 10.68
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 6; n=86	1.6 Beats per minute	Standard Deviation 10.51

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 0; n=107	-0.4 Beats per minute	Standard Deviation 9.42
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 2; n=108	-1.8 Beats per minute	Standard Deviation 10.06
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 6; n=108	-1.4 Beats per minute	Standard Deviation 10.32
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 12; n=106	-4.3 Beats per minute	Standard Deviation 10.03
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 18; n=82	-4.1 Beats per minute	Standard Deviation 9.12
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 24; n=45	-0.9 Beats per minute	Standard Deviation 9.43
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 30; n=37	-0.7 Beats per minute	Standard Deviation 9.23
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 36; n=7	-0.6 Beats per minute	Standard Deviation 5.88
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 48; n=52	-3.2 Beats per minute	Standard Deviation 10.49

Secondary

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores

KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S/ E (1\[Never\] to 4\[All the time\]) and S/ C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 12;n=106,85	-35.22 Scores on a scale	Standard Deviation 35.584
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 24;n=46,22	-23.19 Scores on a scale	Standard Deviation 37.594
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 0;n=80,57	-1.04 Scores on a scale	Standard Deviation 20.6
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 36;n=25,8	-28.67 Scores on a scale	Standard Deviation 34.534
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 36;n=19,6	-7.02 Scores on a scale	Standard Deviation 32.544
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 12;n=106,85	-14.31 Scores on a scale	Standard Deviation 30.03
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 12;n=105,85	-17.67 Scores on a scale	Standard Deviation 31.283
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 36;n=25,8	1.0 Scores on a scale	Standard Deviation 27.46
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 36;n=25,8	-22.00 Scores on a scale	Standard Deviation 33.12
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 0;n=108,88	0.56 Scores on a scale	Standard Deviation 14.757
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 12;n=106,85	-16.23 Scores on a scale	Standard Deviation 25.845
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 12;n=79,54	-6.75 Scores on a scale	Standard Deviation 24.39
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 24;n=47,22	-39.72 Scores on a scale	Standard Deviation 35.193
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 24;n=33,17	-8.59 Scores on a scale	Standard Deviation 27.677
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 24;n=47,22	3.2 Scores on a scale	Standard Deviation 27.39
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 0;n=108,88	-2.78 Scores on a scale	Standard Deviation 26.229
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 0;n=108,88	-2.67 Scores on a scale	Standard Deviation 22.881
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 36;n=25,8	-38.67 Scores on a scale	Standard Deviation 38.103
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 12;n=106,85	-27.88 Scores on a scale	Standard Deviation 29.347
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 0;n= 107,88	-0.31 Scores on a scale	Standard Deviation 23.789
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 24;n=47,22	-28.84 Scores on a scale	Standard Deviation 31.653
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 12;n= 105,85	-24.44 Scores on a scale	Standard Deviation 33.178
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 36;n=25,8	-39.11 Scores on a scale	Standard Deviation 29.766
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 24;n=46,22	-27.17 Scores on a scale	Standard Deviation 31.497
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 0;n=108,88	3.40 Scores on a scale	Standard Deviation 22.986
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 12;n=106,85	-0.2 Scores on a scale	Standard Deviation 25.47
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 36;n=25,8	-30.67 Scores on a scale	Standard Deviation 32.872
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 24;n=47,22	-11.70 Scores on a scale	Standard Deviation 30.676
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 0;n=107,88	2.96 Scores on a scale	Standard Deviation 24.34
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 36;n=25,8	-13.33 Scores on a scale	Standard Deviation 27.639
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 0;n=107,88	0.31 Scores on a scale	Standard Deviation 25.181
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 24;n=46,22	-17.51 Scores on a scale	Standard Deviation 35.136
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 24;n=47,22	-18.01 Scores on a scale	Standard Deviation 28.041
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 12;n=105,85	-24.76 Scores on a scale	Standard Deviation 33.422
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 36;n=25,8	-19.20 Scores on a scale	Standard Deviation 31.465
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 0;n=108,88	8.1 Scores on a scale	Standard Deviation 24.84
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 36;n=25,8	-16.67 Scores on a scale	Standard Deviation 28.284
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 0;n=108,88	2.3 Scores on a scale	Standard Deviation 23.86
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 24;n=47,22	2.3 Scores on a scale	Standard Deviation 24.29
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 0;n=108,88	-11.74 Scores on a scale	Standard Deviation 31.171
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 12;n=106,85	-23.14 Scores on a scale	Standard Deviation 34.512
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 24;n=47,22	-36.36 Scores on a scale	Standard Deviation 30.704
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 12;n= 105,85	-22.35 Scores on a scale	Standard Deviation 28.701
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 24;n=46,22	-9.09 Scores on a scale	Standard Deviation 35.368
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 36;n=25,8	-12.50 Scores on a scale	Standard Deviation 24.801
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 12;n=106,85	2.6 Scores on a scale	Standard Deviation 25.3
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 36;n=25,8	6.3 Scores on a scale	Standard Deviation 29.12
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 36;n=25,8	-37.50 Scores on a scale	Standard Deviation 41.547
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 0;n= 107,88	-7.39 Scores on a scale	Standard Deviation 25.753
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 24;n=46,22	-26.52 Scores on a scale	Standard Deviation 33.198
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 36;n=25,8	-35.42 Scores on a scale	Standard Deviation 38.253
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 0;n=107,88	-4.73 Scores on a scale	Standard Deviation 31.859
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 12;n=105,85	-15.88 Scores on a scale	Standard Deviation 30.851
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 24;n=46,22	-17.42 Scores on a scale	Standard Deviation 38.654
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 36;n=25,8	-31.25 Scores on a scale	Standard Deviation 35.003
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 0;n=107,88	-4.23 Scores on a scale	Standard Deviation 27.733
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 12;n=105,85	-9.35 Scores on a scale	Standard Deviation 28.845
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 36;n=25,8	-23.61 Scores on a scale	Standard Deviation 21.771
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 0;n=80,57	-2.63 Scores on a scale	Standard Deviation 23.944
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 12;n=79,54	-4.63 Scores on a scale	Standard Deviation 26.385
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 24;n=33,17	-14.71 Scores on a scale	Standard Deviation 18.524
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 36;n=19,6	-11.11 Scores on a scale	Standard Deviation 13.608
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 0;n=108,88	-8.08 Scores on a scale	Standard Deviation 26.192
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 12;n=106,85	-14.64 Scores on a scale	Standard Deviation 28.131
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 24;n=47,22	-18.69 Scores on a scale	Standard Deviation 29.574
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Emotions; Week 36;n=25,8	-18.06 Scores on a scale	Standard Deviation 25.845
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 0;n=108,88	-8.90 Scores on a scale	Standard Deviation 24.753
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 12;n=106,85	-13.92 Scores on a scale	Standard Deviation 25.569
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 24;n=47,22	-21.97 Scores on a scale	Standard Deviation 22.647
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 0;n=108,88	-5.61 Scores on a scale	Standard Deviation 23.573
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 12;n=106,85	-11.37 Scores on a scale	Standard Deviation 21.938
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 24;n=47,22	-16.97 Scores on a scale	Standard Deviation 17.785

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 48; n=45	12.18 Milliliter	Standard Deviation 46.394
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 2; n=86	36.72 Milliliter	Standard Deviation 54.171
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 6; n=86	30.26 Milliliter	Standard Deviation 43.818
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 12; n=85	17.06 Milliliter	Standard Deviation 42.424
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 18; n=39	20.15 Milliliter	Standard Deviation 48.934
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 24; n=19	5.38 Milliliter	Standard Deviation 25.57
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 30; n=14	18.61 Milliliter	Standard Deviation 31.086

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 2; n=108	34.87 Milliliter	Standard Deviation 56.255
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 6; n=108	30.11 Milliliter	Standard Deviation 53.625
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 12; n=106	19.33 Milliliter	Standard Deviation 40.498
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 18; n=82	15.09 Milliliter	Standard Deviation 46.604
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 24; n=45	19.11 Milliliter	Standard Deviation 40.219
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 30; n=37	5.66 Milliliter	Standard Deviation 29.172
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 36; n=7	3.69 Milliliter	Standard Deviation 28.76
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 48; n=52	10.98 Milliliter	Standard Deviation 40.499

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 6; n=86	-3.8 Millimeter of mercury	Standard Deviation 16.05
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 12; n=85	-2.8 Millimeter of mercury	Standard Deviation 13.94
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 30; n=14	0.6 Millimeter of mercury	Standard Deviation 10.8
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 48; n=45	-1.8 Millimeter of mercury	Standard Deviation 16.33
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 0; n=87	-1.3 Millimeter of mercury	Standard Deviation 9.59
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 2; n=87	-0.6 Millimeter of mercury	Standard Deviation 10.17
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 6; n=86	-2.6 Millimeter of mercury	Standard Deviation 11.67
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 12; n=85	-2.5 Millimeter of mercury	Standard Deviation 10.55
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 18; n=39	-6.3 Millimeter of mercury	Standard Deviation 9.93
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 24; n=19	-2.3 Millimeter of mercury	Standard Deviation 11.57
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 30; n=14	-0.9 Millimeter of mercury	Standard Deviation 9.53
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 48; n=45	-2.2 Millimeter of mercury	Standard Deviation 9.74
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 0; n=87	-1.6 Millimeter of mercury	Standard Deviation 12.72
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 2; n=87	-1.1 Millimeter of mercury	Standard Deviation 15.93
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 18; n=39	-8.3 Millimeter of mercury	Standard Deviation 12.85
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 24; n=19	1.2 Millimeter of mercury	Standard Deviation 18.38

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 0; n=107	-1.4 Millimeter of mercury	Standard Deviation 14.54
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 2; n=108	-2.0 Millimeter of mercury	Standard Deviation 14.11
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 6; n=108	-2.9 Millimeter of mercury	Standard Deviation 13.7
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 12; n=106	-0.8 Millimeter of mercury	Standard Deviation 13.4
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 18; n=82	-2.6 Millimeter of mercury	Standard Deviation 14.06
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 24; n=45	-1.4 Millimeter of mercury	Standard Deviation 14.51
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 30; n=37	-2.8 Millimeter of mercury	Standard Deviation 15.56
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 36; n=7	-1.9 Millimeter of mercury	Standard Deviation 13.46
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 48; n=52	-1.4 Millimeter of mercury	Standard Deviation 14.03
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 0; n=107	-0.7 Millimeter of mercury	Standard Deviation 10.38
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 2; n=108	-0.7 Millimeter of mercury	Standard Deviation 10.65
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 6; n=108	-1.5 Millimeter of mercury	Standard Deviation 11.43
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 12; n=106	-1.5 Millimeter of mercury	Standard Deviation 11.19
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 18; n=82	-1.6 Millimeter of mercury	Standard Deviation 11.3
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 24; n=45	-1.8 Millimeter of mercury	Standard Deviation 9.73
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 30; n=37	-1.3 Millimeter of mercury	Standard Deviation 9.23
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 36; n=7	1.6 Millimeter of mercury	Standard Deviation 7.18
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 48; n=52	-0.2 Millimeter of mercury	Standard Deviation 8.3

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 48; n=45	0.02 Degree Celsius	Standard Deviation 0.539
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 0; n=87	-0.01 Degree Celsius	Standard Deviation 0.465
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 2; n=87	-0.02 Degree Celsius	Standard Deviation 0.549
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 6; n=86	-0.02 Degree Celsius	Standard Deviation 0.456
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 12; n=85	-0.02 Degree Celsius	Standard Deviation 0.472
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 18; n=39	-0.02 Degree Celsius	Standard Deviation 0.48
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 24; n=19	0.02 Degree Celsius	Standard Deviation 0.459
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 30; n=14	-0.01 Degree Celsius	Standard Deviation 0.403

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U

Population: Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 0; n=107	0.01 Degree Celsius	Standard Deviation 0.505
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 2; n=108	-0.06 Degree Celsius	Standard Deviation 0.485
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 6; n=108	-0.04 Degree Celsius	Standard Deviation 0.433
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 12; n=106	-0.09 Degree Celsius	Standard Deviation 0.446
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 18; n=82	-0.09 Degree Celsius	Standard Deviation 0.469
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 24; n=45	-0.08 Degree Celsius	Standard Deviation 0.526
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 30; n=37	-0.08 Degree Celsius	Standard Deviation 0.458
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 36; n=7	0.06 Degree Celsius	Standard Deviation 0.526
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 48; n=52	-0.12 Degree Celsius	Standard Deviation 0.478

Secondary

Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS2 Population comprised all randomized participants who had at least 1 post-2nd treatment efficacy assessment after 2nd treatment.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=45,21	-3.93 Episodes	Standard Deviation 4.202
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=105,87	-4.34 Episodes	Standard Deviation 3.88
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=106,84	-3.92 Episodes	Standard Deviation 3.76
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=106,85	-3.77 Episodes	Standard Deviation 3.776
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=83,46	-3.75 Episodes	Standard Deviation 3.639
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=36,15	-3.91 Episodes	Standard Deviation 4.366
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=20,6	-4.63 Episodes	Standard Deviation 4.142
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=108,88	-0.54 Episodes	Standard Deviation 3.645
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=36,15	-4.58 Episodes	Standard Deviation 3.967
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=108,88	-2.86 Episodes	Standard Deviation 4.091
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=83,46	-4.21 Episodes	Standard Deviation 3.776
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=105,87	-4.61 Episodes	Standard Deviation 3.61
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=45,21	-5.22 Episodes	Standard Deviation 3.37
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=106,84	-4.44 Episodes	Standard Deviation 3.86
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=20,6	-2.78 Episodes	Standard Deviation 3.06
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=106,85	-4.49 Episodes	Standard Deviation 4.123

Secondary

Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 0; n=108,88	-0.2 Scores on a scale	Standard Deviation 1.78
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 12; n=106,85	-4.1 Scores on a scale	Standard Deviation 3.73
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 24;n=47,22	-5.1 Scores on a scale	Standard Deviation 3.62
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 36; n=25,8	-5.1 Scores on a scale	Standard Deviation 4.04
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 36; n=25,8	-3.9 Scores on a scale	Standard Deviation 3.48
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 0; n=108,88	-1.5 Scores on a scale	Standard Deviation 2.15
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 24;n=47,22	-3.3 Scores on a scale	Standard Deviation 2.78
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score	Week 12; n=106,85	-3.0 Scores on a scale	Standard Deviation 2.89

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U

Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U	3 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U

Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U	3 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings

Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame: Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Population: Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 12; NCS; n=106,85	29 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 48; NCS; n=52,45	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 48; CS; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 12; CS; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 48; CS; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 12; NCS; n=106,85	25 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 12; CS; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings	Week 48; NCS; n=52,45	13 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U	Kidney ultrasound	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U	Bladder ultrasound	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U	Kidney ultrasound	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U	Bladder ultrasound	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6;2 point worsening; n=106, 84	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point worsening; n=106, 84	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point worsening; n=106, 85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point worsening; n=106, 85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point worsening; n=106, 85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point worsening; n=83, 46	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point worsening; n=83, 46	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point worsening; n=45, 21	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point worsening; n=45, 21	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point worsening; n=45, 21	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point worsening; n=36, 15	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point worsening; n=36, 15	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point worsening; n=20, 6	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point worsening; n=20, 6	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point worsening; n=20, 6	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; No change; n=36,15	13 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point improvement; n=105,87	37 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; No change; n=105,87	41 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point improvement; n=106,84	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 2 point improvement; n=106,84	20 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point improvement; n=106,84	29 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; No change; n=106,84	44 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point improvement; n=106,85	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point improvement; n=106,85	17 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point improvement; n=106,85	31 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; No change;n=106,85	48 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point improvement; n=83,46	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point improvement; n=83,46	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point improvement; n=83,46	23 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; No change; n=83,46	37 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point improvement; n=45,21	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point improvement; n=45,21	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point improvement; n=108,88	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point improvement; n=108,88	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point improvement; n=108,88	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point improvement; n=45,21	12 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; No change;n=45,21	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point improvement; n=36,15	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point improvement; n=36,15	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point improvement; n=36,15	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point worsening; n=108,88	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point improvement; n=20,6	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point improvement; n=20,6	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point improvement; n=20,6	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; No change; n=20,6	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point worsening; n=108,88	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point worsening; n=108,88	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point worsening; n=105,87	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point worsening; n=105, 87	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point worsening; n=105, 87	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point worsening; n=106, 84	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; No change; n=108,88	83 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point improvement; n=105,87	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point improvement; n=105,87	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point worsening; n=83, 46	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point worsening; n=36, 15	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point improvement; n=83,46	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point worsening; n=105, 87	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point worsening; n=106, 84	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point improvement; n=83,46	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point worsening; n=106, 85	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point improvement; n=20,6	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point worsening; n=106, 85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; No change; n=83,46	22 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point worsening; n=106, 85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point worsening; n=83, 46	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point worsening; n=106, 84	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point worsening; n=83, 46	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point improvement; n=45,21	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point worsening; n=83, 46	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point improvement; n=20,6	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point worsening; n=45, 21	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point improvement; n=45,21	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point worsening; n=45, 21	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point worsening; n=105, 87	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point worsening; n=45, 21	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point improvement; n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point worsening; n=36, 15	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point worsening; n=36, 15	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; No change; n=20,6	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point worsening; n=36, 15	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point improvement; n=108,88	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 1 point worsening; n=20, 6	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point improvement; n=105,87	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 2 point worsening; n=20, 6	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; No change; n=36,15	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point worsening; n=20, 6	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point worsening; n=108,88	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point improvement; n=105,87	14 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point improvement; n=45,21	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point improvement; n=105,87	27 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point improvement; n=108,88	24 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; No change; n=105,87	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; No change;n=45,21	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point improvement; n=106,84	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point worsening; n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 2 point improvement; n=106,84	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 3 point improvement; n=36,15	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point improvement; n=106,84	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point worsening; n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; No change; n=106,84	34 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 2 point improvement; n=36,15	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point improvement; n=106,85	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6;2 point worsening; n=106, 84	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point improvement; n=106,85	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 30; 1 point improvement; n=36,15	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point improvement; n=106,85	27 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point worsening; n=105,87	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; No change;n=106,85	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; No change; n=108,88	54 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point improvement; n=83,46	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 36; 3 point improvement; n=20,6	1 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity

Time frame: Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 0; n=108,88	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 6; n=106,84	27 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 12; n=106,85	13 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 18; n=83,46	35 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 36; n=20,6	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 36; n=20,6	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 36; n=20,6	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 0; n=108,88	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 0; n=108,88	20 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 0; n=108,88	82 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 2; n=105,87	12 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 2; n=105,87	21 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 2; n=105,87	35 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 2; n=105,87	37 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 6; n=106,84	13 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 6; n=106,84	25 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 6; n=106,84	41 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 12; n=106,85	23 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 12; n=106,85	28 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 12; n=106,85	42 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 18; n=83,46	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 18; n=83,46	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 18; n=83,46	21 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 24; n=45,21	13 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 24; n=45,21	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 24; n=45,21	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 24; n=45,21	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 30; n=36,15	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 30; n=36,15	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 30; n=36,15	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 30; n=36,15	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 36; n=20,6	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 6; n=106,84	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 18; n=83,46	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 6; n=106,84	36 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 6; n=106,84	27 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 12; n=106,85	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 30; n=36,15	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 18; n=83,46	23 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 24; n=45,21	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 24; n=45,21	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 24; n=45,21	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 36; n=20,6	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 12; n=106,85	11 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 36; n=20,6	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 36; n=20,6	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 36; n=20,6	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 0; n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 12; n=106,85	25 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 0; n=108,88	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 30; n=36,15	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 0; n=108,88	24 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 12; n=106,85	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 0; n=108,88	54 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 30; n=36,15	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 2; n=105,87	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 18; n=83,46	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 2; n=105,87	17 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 24; n=45,21	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 2; n=105,87	24 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Mild; Week 18; n=83,46	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Severe; Week 2; n=105,87	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	Moderate; Week 30; n=36,15	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity	None; Week 6; n=106,84	9 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U	Any SAE	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U	Any non-SAE	40 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U	Any SAE	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U	Any non-SAE	49 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results

Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To High; n=52,45	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To High; n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Normal or No Change; n=52,45	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium;To Normal or No Change; n=106,85	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To High; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Low; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Normal or No Change; n=52,45	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST;To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Normal or No Change; n=106,85	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To Low; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium;To Normal or No Change; n=106,85	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To Normal or No Change; n=52,45	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To Low; n=52,45	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Low; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium;To Normal or No Change; n=52,45	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Normal or No Change; n=52,45	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To Low; n=106,85	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To High; n=52,45	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12: T Protein;To Normal or No Change;n=106,85	95 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Low; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To High; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil;To Normal or NoChange; n=106,85	104 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To Low; n=52,45	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Normal or No Change; n=106,85	103 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein;To Normal or No Change; n=52,45	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To High; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To Low; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT; To High; n=52,45	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12Urea/BUN; To Normal or No Change; n=106,85	101 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Low; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To High; n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Normal or No Change; n=52,45	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Low; n=52,45	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil;To Normal or No Change;n=106,85	106 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Normal or No Change; n=52,45	47 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To High; n=52,45	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To Low; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid;To Normal or No Change;n=106,85	98 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To High; n=106,85	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine;To Normal or NoChange; n=106,85	104 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To Low; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid;To Normal or No Change; n=52,45	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To High; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To High; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 12:Albumin; To Low; n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST;To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To Normal or No Change; n=106,85	103 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Low; n=52,45	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 48:Albumin; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Normal or No Change; n=52,45	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Normal or No Change; n=52,45	45 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To Low; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp;To Normal or No Change;n=106,85	98 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To High; n=52,45	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To High; n=106,85	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Low; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp;To Normal or No Change;n=52,45	49 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To Normal or No Change; n=52,45	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To High; n=52,45	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Normal or No Change; n=106,85	90 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To Normal or No Change; n=106,85	103 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Normal or No Change; n=106,85	104 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To High; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT; To High; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To High; n=106,85	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Normal or No Change; n=52,45	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Normal or No Change; n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Normal or No Change; n=52,45	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Normal or No Change; n=52,45	45 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To High; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Normal or No Change; n=52,45	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Normal or No Change; n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium;To Normal or No Change; n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT; To High; n=52,45	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST;To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To Normal or No Change; n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To High; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST;To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To Normal or No Change; n=52,45	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To High; n=52,45	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil;To Normal or No Change;n=106,85	84 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil;To Normal or NoChange; n=106,85	84 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To High; n=52,45	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Normal or No Change; n=106,85	84 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To High; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To High; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Low; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Normal or No Change; n=106,85	82 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Normal or No Change; n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To High; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine;To Normal or NoChange; n=106,85	84 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Normal or No Change; n=52,45	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To High; n=52,45	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Low; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Normal or No Change; n=106,85	72 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To High; n=106,85	11 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Normal or No Change; n=52,45	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To High; n=52,45	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To Low; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To High; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Normal or No Change; n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To High; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium;To Normal or No Change; n=106,85	84 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To High; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium;To Normal or No Change; n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To High; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To Low; n=106,85	14 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12: T Protein;To Normal or No Change;n=106,85	71 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To High; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To Low; n=52,45	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein;To Normal or No Change; n=52,45	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To High; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To Low; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12Urea/BUN; To Normal or No Change; n=106,85	78 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To High; n=106,85	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Normal or No Change; n=52,45	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To High; n=52,45	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid;To Normal or No Change;n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid;To Normal or No Change; n=52,45	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To High; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 12:Albumin; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To Normal or No Change; n=106,85	85 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 48:Albumin; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To Normal or No Change; n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To High; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp;To Normal or No Change;n=106,85	81 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To High; n=106,85	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp;To Normal or No Change;n=52,45	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To High; n=52,45	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Normal or No Change; n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT; To High; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To High; n=106,85	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Monocytes; To Low; n=52,44	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hb; To Normal or No Change; n=52,45	49 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes;To Normal or No Change;n=52,44	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino;To Normal or No Change;n=106,85	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes; To High; n=52,44	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:N bands; To Low; n=106,85	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands;To Normal or No Change;n=106,85	104 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To Low; n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Eosino; To High; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:N bands; To Low; n=52,44	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hct;To Normal or No Change; n=106,85	100 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands;To Normal or No Change;n=52,44	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Normal or No Change;n=52,44	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands; To High; n=52,44	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To High; n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To Low; n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro;To Normal or No Change;n=106,85	103 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To Low; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To Low; n=52,44	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hct;To Normal or No Change; n=52,45	48 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro;To Normal or No Change;n=52,44	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino;To Normal or No Change;n=52,45	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To High; n=52,44	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To High; n=52,45	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:PC; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils; To High; n=52,44	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:PC; To Normal or No Change; n=106,85	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: PC; To High;n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Eosino; To High; n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:PC; To Low; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Lympho; To Normal or No Change; n=106,85	101 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:PC; To Normal or No Change; n=52,45	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Normal or No Change;n=106,85	106 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: PC; To High;n=52,45	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To High; n=106,85	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count; To Low;n=106,85	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb;To Low;n=106,85	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To Normal or No Change;n=106,85	98 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To Low; n=52,44	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To High;n=106,85	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hb; To Normal or No Change; n=106,85	101 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count; To Low;n=52,45	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Lympho; To Normal or No Change; n=52,44	49 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To Normal or No Change;n=52,45	47 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino; To Low; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To High;n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To High; n=52,44	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To Low;n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb; To High; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count;To Normal or No Change;n=106,85	106 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To Low; n=106,85	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb;To Low;n=52,45	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To Low;n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Monocytes;To Normal or No Change;n=106,85	105 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count;To Normal or No Change;n=52,45	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To High; n=106,85	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To High; n=52,45	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Low; n=52,44	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To High; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Monocytes;To Normal or No Change;n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Normal or No Change;n=106,85	85 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils; To High; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Low; n=52,44	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Normal or No Change;n=52,44	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils; To High; n=52,44	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino;To Normal or No Change;n=106,85	85 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Eosino; To High; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino;To Normal or No Change;n=52,45	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Eosino; To High; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hb; To Normal or No Change; n=106,85	81 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb;To Low;n=52,45	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hb; To Normal or No Change; n=52,45	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb; To High; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hct;To Normal or No Change; n=106,85	80 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To High; n=106,85	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To Low; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hct;To Normal or No Change; n=52,45	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To High; n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Lympho; To Normal or No Change; n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To Low; n=52,44	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Lympho; To Normal or No Change; n=52,44	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To High; n=52,44	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Monocytes; To Low; n=52,44	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes;To Normal or No Change;n=52,44	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes; To High; n=52,44	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:N bands; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands;To Normal or No Change;n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands; To High; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:N bands; To Low; n=52,44	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands;To Normal or No Change;n=52,44	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands; To High; n=52,44	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To Low; n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro;To Normal or No Change;n=106,85	82 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To High; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To Low; n=52,44	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro;To Normal or No Change;n=52,44	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To High; n=52,44	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:PC; To Low; n=106,85	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:PC; To Normal or No Change; n=106,85	83 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: PC; To High;n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:PC; To Low; n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:PC; To Normal or No Change; n=52,45	45 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: PC; To High;n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count; To Low;n=106,85	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To Normal or No Change;n=106,85	80 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To High;n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count; To Low;n=52,45	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To Normal or No Change;n=52,45	44 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To High;n=52,45	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To Low;n=106,85	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count;To Normal or No Change;n=106,85	82 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To High; n=106,85	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To Low;n=52,45	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count;To Normal or No Change;n=52,45	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb;To Low;n=106,85	3 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U	19 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 100 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 1.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 100 U	30 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline

Time frame: Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; No Change/Decreased, n=108,88	70 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Any Increase, n=108,88	38 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to Traces, n=108,88	12 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 1+, n=108,88	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 2+, n=108,88	11 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 3+, n=108,88	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 4+, n=108,88	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;No Change/Decreased, n=108,88	80 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;Any Increase, n=108,88	28 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to Traces, n=108,88	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 1+, n=108,88	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 2+, n=108,88	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 3+, n=108,88	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 4+, n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 1+, n=108,88	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; No Change/Decreased, n=108,88	54 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;No Change/Decreased, n=108,88	72 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Any Increase, n=108,88	34 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 3+, n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to Traces, n=108,88	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;Any Increase, n=108,88	16 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 1+, n=108,88	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 2+, n=108,88	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 2+, n=108,88	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to Traces, n=108,88	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 3+, n=108,88	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 4+, n=108,88	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 4+, n=108,88	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=20,6	39.51 Percent change	Standard Deviation 76.822
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=106,85	21.92 Percent change	Standard Deviation 41.446
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=103,87	16.62 Percent change	Standard Deviation 41.294
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=108,88	1.72 Percent change	Standard Deviation 28.347
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=45,20	30.10 Percent change	Standard Deviation 54.874
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=106,84	21.50 Percent change	Standard Deviation 44.146
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=36,15	33.02 Percent change	Standard Deviation 69.583
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=83,46	25.12 Percent change	Standard Deviation 38.53
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 30; n=36,15	20.14 Percent change	Standard Deviation 35.588
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 36; n=20,6	13.35 Percent change	Standard Deviation 52.1
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=108,88	24.71 Percent change	Standard Deviation 38.824
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=103,87	21.94 Percent change	Standard Deviation 39.385
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=106,84	28.51 Percent change	Standard Deviation 43.091
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=106,85	23.99 Percent change	Standard Deviation 42.719
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=83,46	12.60 Percent change	Standard Deviation 34
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=45,20	19.48 Percent change	Standard Deviation 30.916

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=108,88	-0.97 Percent change	Standard Deviation 53.493
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=105,87	-34.51 Percent change	Standard Deviation 75.956
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=106,84	-46.94 Percent change	Standard Deviation 41.256
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=106,85	-44.42 Percent change	Standard Deviation 58.087
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=83,46	-41.83 Percent change	Standard Deviation 60.854
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=45,21	-50.30 Percent change	Standard Deviation 62.946
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=36,15	-43.83 Percent change	Standard Deviation 76.751
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=20,6	-42.83 Percent change	Standard Deviation 100.717
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 36; n=20,6	17.36 Percent change	Standard Deviation 163.104
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=108,88	-17.59 Percent change	Standard Deviation 52.475
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=83,46	-37.30 Percent change	Standard Deviation 57.929
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=105,87	-43.19 Percent change	Standard Deviation 48.933
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 30; n=36,15	-47.11 Percent change	Standard Deviation 35.298
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=106,84	-42.81 Percent change	Standard Deviation 48.411
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=45,21	-50.18 Percent change	Standard Deviation 36.257
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=106,85	-37.61 Percent change	Standard Deviation 44.355

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=108,88	6.68 Percent change	Standard Deviation 82.009
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=83,46	-58.48 Percent change	Standard Deviation 38.5
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=106,84	-65.64 Percent change	Standard Deviation 42.063
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=45,21	-62.54 Percent change	Standard Deviation 53.503
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=36,15	-62.58 Percent change	Standard Deviation 46.592
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=105,87	-67.19 Percent change	Standard Deviation 45.799
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=20,6	-71.28 Percent change	Standard Deviation 33.179
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=106,85	-62.41 Percent change	Standard Deviation 45.304
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 36; n=20,6	-65.09 Percent change	Standard Deviation 42.285
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=108,88	-29.45 Percent change	Standard Deviation 51.218
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=105,87	-65.02 Percent change	Standard Deviation 34.778
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=106,84	-61.88 Percent change	Standard Deviation 43.428
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=106,85	-57.43 Percent change	Standard Deviation 45.561
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=83,46	-59.90 Percent change	Standard Deviation 47.789
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 30; n=36,15	-72.34 Percent change	Standard Deviation 29.508
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=45,21	-79.20 Percent change	Standard Deviation 24.398

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=108,88	7.31 Percent change	Standard Deviation 67.536
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=105,87	-64.76 Percent change	Standard Deviation 61.7
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=106,84	-66.00 Percent change	Standard Deviation 42.442
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=106,85	-61.39 Percent change	Standard Deviation 49.37
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=83,46	-57.93 Percent change	Standard Deviation 39.299
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=45,21	-59.10 Percent change	Standard Deviation 72.369
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=36,15	-63.64 Percent change	Standard Deviation 51.577
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=20,6	-74.12 Percent change	Standard Deviation 32.549
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 36; n=20,6	-65.09 Percent change	Standard Deviation 42.285
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=108,88	-27.01 Percent change	Standard Deviation 57.513
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=83,46	-59.27 Percent change	Standard Deviation 48.577
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=105,87	-66.40 Percent change	Standard Deviation 35.804
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 30; n=36,15	-72.34 Percent change	Standard Deviation 29.508
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=106,84	-61.50 Percent change	Standard Deviation 43.73
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=45,21	-79.37 Percent change	Standard Deviation 24.927
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=106,85	-55.11 Percent change	Standard Deviation 50.258

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 0; n=108,88	-0.31 Percent change	Standard Deviation 20.076
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 2; n=105,87	-11.53 Percent change	Standard Deviation 26.466
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 6; n=106,84	-14.87 Percent change	Standard Deviation 23.844
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 36; n=20,6	-19.03 Percent change	Standard Deviation 20.561
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 12; n=106,85	-15.78 Percent change	Standard Deviation 26.649
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 18; n=83,46	-19.08 Percent change	Standard Deviation 18.022
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 24; n=45,21	-22.08 Percent change	Standard Deviation 16.561
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 30; n=36,15	-19.22 Percent change	Standard Deviation 21.626
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 30; n=36,15	-18.90 Percent change	Standard Deviation 20.805
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 0; n=108,88	-10.14 Percent change	Standard Deviation 18.892
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 12; n=106,85	-14.52 Percent change	Standard Deviation 20.26
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 2; n=105,87	-11.11 Percent change	Standard Deviation 30.081
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 24; n=45,21	-18.61 Percent change	Standard Deviation 20.308
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 18; n=83,46	-10.88 Percent change	Standard Deviation 22.318
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 36; n=20,6	-2.57 Percent change	Standard Deviation 24.843
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids	Week 6; n=106,84	-16.31 Percent change	Standard Deviation 23.417

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. All the participants in this population were analyzed (108, 88 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=97,71	-19.84 Percent change	Standard Deviation 60.168
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=38,19	-17.35 Percent change	Standard Deviation 60.337
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=97,72	-17.89 Percent change	Standard Deviation 70.405
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=96,74	-10.92 Percent change	Standard Deviation 68.689
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=75,39	-16.10 Percent change	Standard Deviation 68.014
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=30,14	-5.38 Percent change	Standard Deviation 95.013
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=16,6	-1.55 Percent change	Standard Deviation 91.218
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=99,75	1.84 Percent change	Standard Deviation 63.835
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 36; n=16,6	28.61 Percent change	Standard Deviation 86.861
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=99,75	-12.98 Percent change	Standard Deviation 68.669
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=75,39	-12.99 Percent change	Standard Deviation 55.055
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=38,19	-4.88 Percent change	Standard Deviation 52.277
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=97,71	-16.88 Percent change	Standard Deviation 71.816
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=97,72	-15.74 Percent change	Standard Deviation 65.355
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 30; n=30,14	-4.66 Percent change	Standard Deviation 59.94
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=96,74	-19.95 Percent change	Standard Deviation 56.983

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=75%; n=106, 84	58 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=75%; n=108,88	6 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=50%; n=108,88	19 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; 100 %; n=105, 87	30 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=75%; n=105, 87	57 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=50%; n=105, 87	81 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; 100 %; n=106, 84	35 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; 100%; n=108,88	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=50%; n=106, 84	71 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; 100 %; n=106, 85	27 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=75%; n=106, 85	53 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=50%; n=106, 85	74 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; 100 %; n=83, 46	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=75%; n=83, 46	43 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; 100 %; n=45, 21	40 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=75%; n=45, 21	56 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=50%; n=45, 21	71 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; 100 %; n=36, 15	22 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=75%; n=36, 15	53 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=50%; n=36, 15	75 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; 100 %; n=20, 6	45 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=75%; n=20, 6	55 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=50%; n=20, 6	75 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=50%; n=83, 46	66 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=50%; n=20, 6	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; 100%; n=108,88	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; 100 %; n=45, 21	38 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=75%; n=108,88	17 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=50%; n=108,88	42 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; 100 %; n=105, 87	20 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=50%; n=45, 21	86 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=75%; n=105, 87	53 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=75%; n=106, 85	41 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=50%; n=105, 87	71 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; 100 %; n=36, 15	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; 100 %; n=106, 84	18 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=75%; n=83, 46	43 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=75%; n=106, 84	57 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=75%; n=36, 15	47 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=50%; n=106, 84	71 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; >=75%; n=20, 6	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; 100 %; n=106, 85	19 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=50%; n=83, 46	72 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 36; 100 %; n=20, 6	33 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=50%; n=106, 85	64 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=75%; n=45, 21	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; 100 %; n=83, 46	28 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 30; >=50%; n=36, 15	80 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; 100 %; n=20, 6	50 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=75%; n=108,88	6 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=50%; n=108,88	19 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; 100 %; n=105, 87	31 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=75%; n=105, 87	57 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=50%; n=105, 87	80 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; 100 %; n=106, 84	35 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=50%; n=106, 84	71 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; 100 %; n=106, 85	28 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=75%; n=106, 85	55 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=50%; n=106, 85	73 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; 100 %; n=83, 46	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=75%; n=83, 46	45 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=50%; n=83, 46	65 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; 100 %; n=45, 21	42 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=75%; n=45, 21	56 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=50%; n=45, 21	73 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; 100 %; n=36, 15	31 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=75%; n=36, 15	61 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=50%; n=36, 15	75 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=75%; n=20, 6	60 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; 100%; n=108,88	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=75%; n=106, 84	59 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=50%; n=20, 6	75 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=50%; n=20, 6	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; 100 %; n=45, 21	38 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=75%; n=108,88	17 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; 100 %; n=36, 15	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=75%; n=45, 21	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=50%; n=108,88	42 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=75%; n=105, 87	56 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=50%; n=45, 21	86 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; 100 %; n=105, 87	24 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; 100 %; n=106, 84	20 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=75%; n=106, 84	57 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=50%; n=105, 87	72 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=50%; n=106, 84	71 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=75%; n=36, 15	47 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; 100 %; n=20, 6	33 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=75%; n=106, 85	42 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 30; >=50%; n=36, 15	80 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=50%; n=106, 85	64 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; 100%; n=108,88	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; 100 %; n=83, 46	28 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; 100 %; n=106, 85	19 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=75%; n=83, 46	43 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 36; >=75%; n=20, 6	67 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=50%; n=83, 46	74 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS

Time frame: Week 0, Week 2, Week 6, Week 12, Week 24 and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 36; n=25,8	68 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 2; n=108,86	81 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 24; n=47,22	72 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 6; n=108,86	79 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 0; n=108,88	7 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 12; n=106,85	73 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 0; n=108,88	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 24; n=47,22	55 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 36; n=25,8	38 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 12; n=106,85	64 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 2; n=108,86	70 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS	Week 6; n=108,86	69 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=56,43	19.49 Milliliter	Standard Deviation 36.341
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=55,43	20.32 Milliliter	Standard Deviation 38.05
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=53,41	28.13 Milliliter	Standard Deviation 41.894
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=53,41	24.51 Milliliter	Standard Deviation 39.67
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=22,29	23.51 Milliliter	Standard Deviation 56.849
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=2,4	-6.79 Milliliter	Standard Deviation 2.18
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=22,29	18.09 Milliliter	Standard Deviation 35.324
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=56,43	25.60 Milliliter	Standard Deviation 35.923
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=53,41	17.33 Milliliter	Standard Deviation 45.658
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=55,43	25.01 Milliliter	Standard Deviation 46.534
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=2,4	15.57 Milliliter	Standard Deviation 45.613
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=53,41	20.39 Milliliter	Standard Deviation 47.654

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=2,4	0.33 Episodes	Standard Deviation 0.471
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=22,29	-0.50 Episodes	Standard Deviation 1.212
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=56,43	-0.44 Episodes	Standard Deviation 1.314
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=55,43	-0.44 Episodes	Standard Deviation 1.41
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=53,42	-0.46 Episodes	Standard Deviation 1.299
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=53,41	-0.72 Episodes	Standard Deviation 1.396
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=53,42	-0.29 Episodes	Standard Deviation 1.07
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=55,43	-0.31 Episodes	Standard Deviation 1.012
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=22,29	-0.34 Episodes	Standard Deviation 1.449
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=2,4	-0.33 Episodes	Standard Deviation 0.72
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=53,41	-0.47 Episodes	Standard Deviation 1.093
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=56,43	-0.29 Episodes	Standard Deviation 1.032

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 0; n=56,43	-2.11 Episodes	Standard Deviation 3.132
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 2; n=55,43	-2.47 Episodes	Standard Deviation 3.603
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 6; n=53,42	-2.58 Episodes	Standard Deviation 2.819
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 12; n=53,41	-2.23 Episodes	Standard Deviation 2.734
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 18; n=22,29	-1.89 Episodes	Standard Deviation 3.155
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 24; n=2,4	-3.33 Episodes	Standard Deviation 0
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 18; n=22,29	-2.98 Episodes	Standard Deviation 4.134
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 0; n=56,43	-3.39 Episodes	Standard Deviation 4.082
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 12; n=53,41	-3.50 Episodes	Standard Deviation 3.936
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 2; n=55,43	-4.09 Episodes	Standard Deviation 4.104
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 24; n=2,4	-3.33 Episodes	Standard Deviation 4.815
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes	Week 6; n=53,42	-4.18 Episodes	Standard Deviation 3.842

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes

The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 18; n=22,29	-1.32 Episodes	Standard Deviation 2.466
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 12; n=53,41	-1.24 Episodes	Standard Deviation 2.35
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 6; n=53,42	-1.42 Episodes	Standard Deviation 2.245
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 2; n=55,43	-1.66 Episodes	Standard Deviation 2.658
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 24; n=2,4	-0.83 Episodes	Standard Deviation 1.179
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 0; n=56,43	-1.58 Episodes	Standard Deviation 2.357
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 24; n=2,4	-1.92 Episodes	Standard Deviation 1.424
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 6; n=53,42	-3.41 Episodes	Standard Deviation 4.901
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 0; n=56,43	-3.05 Episodes	Standard Deviation 4.381
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 2; n=55,43	-3.52 Episodes	Standard Deviation 4.843
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 12; n=53,41	-3.24 Episodes	Standard Deviation 4.814
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes	Week 18; n=22,29	-3.28 Episodes	Standard Deviation 5.587

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=2,4	-2.17 Episodes	Standard Deviation 1.65
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=55,43	-3.28 Episodes	Standard Deviation 4.476
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=56,43	-2.64 Episodes	Standard Deviation 3.362
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=53,42	-3.50 Episodes	Standard Deviation 3.878
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=53,41	-3.28 Episodes	Standard Deviation 3.3
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=22,29	-3.14 Episodes	Standard Deviation 4.082
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=53,42	-4.40 Episodes	Standard Deviation 4.257
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=2,4	-2.00 Episodes	Standard Deviation 2.48
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=22,29	-2.97 Episodes	Standard Deviation 3.654
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=53,41	-3.63 Episodes	Standard Deviation 4.093
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=56,43	-3.22 Episodes	Standard Deviation 3.668
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=55,43	-3.89 Episodes	Standard Deviation 4.286

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=56,43	-2.69 Episodes	Standard Deviation 3.554
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=55,43	-3.38 Episodes	Standard Deviation 4.221
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=53,42	-3.31 Episodes	Standard Deviation 3.592
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=53,41	-3.31 Episodes	Standard Deviation 3.567
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=22,29	-2.67 Episodes	Standard Deviation 4.505
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=2,4	-2.17 Episodes	Standard Deviation 1.65
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=22,29	-3.59 Episodes	Standard Deviation 5.137
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=56,43	-3.68 Episodes	Standard Deviation 4.521
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=53,41	-4.53 Episodes	Standard Deviation 4.624
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=55,43	-4.37 Episodes	Standard Deviation 4.823
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=2,4	-1.33 Episodes	Standard Deviation 0.609
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=53,42	-4.74 Episodes	Standard Deviation 4.946

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 0; n=56,43	-1.58 Voids	Standard Deviation 3.166
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 2; n=55,43	-1.57 Voids	Standard Deviation 3.476
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 24; n=2,4	-1.33 Voids	Standard Deviation 0.943
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 6; n=53,42	-1.85 Voids	Standard Deviation 2.917
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 12; n=53,41	-1.95 Voids	Standard Deviation 2.836
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 18; n=22,29	-2.12 Voids	Standard Deviation 3.766
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 12; n=53,41	-2.02 Voids	Standard Deviation 2.173
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 0; n=56,43	-2.12 Voids	Standard Deviation 2.495
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 6; n=53,42	-2.62 Voids	Standard Deviation 2.623
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 18; n=22,29	-1.74 Voids	Standard Deviation 2.327
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 24; n=2,4	-1.08 Voids	Standard Deviation 0.877
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids	Week 2; n=55,43	-2.29 Voids	Standard Deviation 2.864

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 0; n=43	1.2 Beats per minute	Standard Deviation 12.33
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 2; n=43	-3.3 Beats per minute	Standard Deviation 9.69
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 6; n=43	-3.1 Beats per minute	Standard Deviation 10.19
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 12; n=40	-5.7 Beats per minute	Standard Deviation 10.99
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 18; n=27	-3.7 Beats per minute	Standard Deviation 11.57
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U	Week 48; n=43	-2.5 Beats per minute	Standard Deviation 11.2

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 0; n=56	0.2 Beats per minute	Standard Deviation 9.28
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 2; n=56	-2.3 Beats per minute	Standard Deviation 9.26
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 6; n=55	-2.9 Beats per minute	Standard Deviation 9.24
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 12; n=53	-3.8 Beats per minute	Standard Deviation 10.28
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 18; n=19	-0.6 Beats per minute	Standard Deviation 11.08
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 24; n=1	6.0 Beats per minute	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U	Week 48; n=56	-1.8 Beats per minute	Standard Deviation 11.47

Secondary

Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 12;n=54,42	-17.28 Scores on a scale	Standard Deviation 26.095
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 24;n=2,7	37.5 Scores on a scale	Standard Deviation 17.68
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 24;n=2,7	-25.00 Scores on a scale	Standard Deviation 11.785
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 12;n=54,42	-21.91 Scores on a scale	Standard Deviation 28.724
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 0;n=55,43	-11.15 Scores on a scale	Standard Deviation 18.417
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 12;n=54,42	-34.57 Scores on a scale	Standard Deviation 29.647
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 0;n=55,43	3.6 Scores on a scale	Standard Deviation 22.27
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 24;n=2,7	-6.67 Scores on a scale	Standard Deviation 9.428
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 24;n=2,7	-5.56 Scores on a scale	Standard Deviation 7.857
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 24;n=2,7	0.00 Scores on a scale	Standard Deviation 0
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 0;n=55,43	-24.24 Scores on a scale	Standard Deviation 32.365
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 12;n=40,24	-9.58 Scores on a scale	Standard Deviation 19.203
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 0;n=55,43	-19.09 Scores on a scale	Standard Deviation 27.67
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 0;n=55,43	-16.67 Scores on a scale	Standard Deviation 26.058
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 12;n=54,42	-25.62 Scores on a scale	Standard Deviation 33.912
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 12;n=54,42	-3.2 Scores on a scale	Standard Deviation 19.45
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 12;n=54,42	-29.32 Scores on a scale	Standard Deviation 29.662
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Emotions; Week 24;n=2,7	-22.22 Scores on a scale	Standard Deviation 15.713
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 24;n=2,7	0.00 Scores on a scale	Standard Deviation 0
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 0;n=42,23	-7.14 Scores on a scale	Standard Deviation 16.926
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 24;n=2,7	0.00 Scores on a scale	Standard Deviation 0
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 24;n=1,4	-16.67 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 0;n=55,43	-10.61 Scores on a scale	Standard Deviation 22.536
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Emotions; Week 0;n=55,43	-19.39 Scores on a scale	Standard Deviation 22.551
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 0;n=55,43	-17.68 Scores on a scale	Standard Deviation 24.195
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Emotions; Week 12;n=54,42	-27.98 Scores on a scale	Standard Deviation 28.776
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 12;n=54,42	-16.67 Scores on a scale	Standard Deviation 20.992
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 12;n=54,42	-4.76 Scores on a scale	Standard Deviation 23.013
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 0;n=55,43	6.4 Scores on a scale	Standard Deviation 26.78
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 12;n=54,42	-2.4 Scores on a scale	Standard Deviation 29.64
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 12;n=54,42	-16.67 Scores on a scale	Standard Deviation 36.994
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 0;n=55,43	-15.12 Scores on a scale	Standard Deviation 27.892
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 12;n=54,42	-10.32 Scores on a scale	Standard Deviation 28.023
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 0;n=55,43	-13.95 Scores on a scale	Standard Deviation 29.531
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 24;n=2,7	-28.57 Scores on a scale	Standard Deviation 39.34
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 0;n=55,43	-6.07 Scores on a scale	Standard Deviation 24.899
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 12;n=54,42	-7.54 Scores on a scale	Standard Deviation 26.311
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Social Limitations; Week 24;n=2,7	-7.94 Scores on a scale	Standard Deviation 19.994
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 12;n=40,24	4.17 Scores on a scale	Standard Deviation 18.553
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Emotions; Week 12;n=54,42	-8.47 Scores on a scale	Standard Deviation 26.749
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Emotions; Week 24;n=2,7	-7.94 Scores on a scale	Standard Deviation 21.956
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 0;n=55,43	-7.75 Scores on a scale	Standard Deviation 24.76
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 12;n=54,42	-10.71 Scores on a scale	Standard Deviation 25.72
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Sleep/Energy; Week 24;n=2,7	-7.14 Scores on a scale	Standard Deviation 26.972
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 0;n=55,43	-2.02 Scores on a scale	Standard Deviation 17.429
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Severity/Coping Measures; Week 24;n=2,7	-3.81 Scores on a scale	Standard Deviation 18.402
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	General Health Perception; Week 24;n=2,7	-7.1 Scores on a scale	Standard Deviation 53.45
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 0;n=55,43	-10.08 Scores on a scale	Standard Deviation 32.962
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Incontinence Impact; Week 24;n=2,7	-14.29 Scores on a scale	Standard Deviation 26.227
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Role Limitations; Week 24;n=2,7	-7.14 Scores on a scale	Standard Deviation 28.637
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Physical Limitations; Week 12;n=54,42	-12.70 Scores on a scale	Standard Deviation 32.05
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 0;n=42,23	2.90 Scores on a scale	Standard Deviation 17.875
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Personal Relationships; Week 24;n=1,4	16.67 Scores on a scale	Standard Deviation 56.108
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores	Emotions; Week 0;n=55,43	-10.08 Scores on a scale	Standard Deviation 28.772

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 2; n=43	50.13 Milliliter	Standard Deviation 59.96
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 6; n=43	28.09 Milliliter	Standard Deviation 42.401
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 12; n=40	24.96 Milliliter	Standard Deviation 42.308
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 18; n=27	14.54 Milliliter	Standard Deviation 42.237
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U	Week 48; n=43	22.85 Milliliter	Standard Deviation 48.338

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 2; n=56	49.97 Milliliter	Standard Deviation 64.295
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 6; n=55	36.32 Milliliter	Standard Deviation 49.891
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 12; n=53	25.20 Milliliter	Standard Deviation 49.651
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 18; n=19	32.57 Milliliter	Standard Deviation 59.514
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 24; n=1	39.10 Milliliter	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U	Week 48; n=56	26.65 Milliliter	Standard Deviation 54.171

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 0; n=43	-3.0 Millimeter of mercury	Standard Deviation 15.49
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 2; n=43	-2.5 Millimeter of mercury	Standard Deviation 16
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 6; n=43	-4.5 Millimeter of mercury	Standard Deviation 15.85
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 12; n=40	-3.2 Millimeter of mercury	Standard Deviation 17.5
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 18; n=27	-3.4 Millimeter of mercury	Standard Deviation 13.58
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	SBP; Week 48; n=43	-4.7 Millimeter of mercury	Standard Deviation 14.62
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 0; n=43	-1.1 Millimeter of mercury	Standard Deviation 10.21
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 2; n=43	-3.1 Millimeter of mercury	Standard Deviation 10.68
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 6; n=43	-3.7 Millimeter of mercury	Standard Deviation 10.08
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 18; n=27	-1.5 Millimeter of mercury	Standard Deviation 7.65
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 48; n=43	-4.0 Millimeter of mercury	Standard Deviation 10.95
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U	DBP; Week 12; n=40	-1.2 Millimeter of mercury	Standard Deviation 10.21

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 12; n=53	-3.9 Millimeter of mercury	Standard Deviation 17.7
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 18; n=19	-3.2 Millimeter of mercury	Standard Deviation 12.08
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 24; n=1	-23.0 Millimeter of mercury	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 48; n=56	-1.7 Millimeter of mercury	Standard Deviation 13.58
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 0; n=56	-0.9 Millimeter of mercury	Standard Deviation 10.19
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 2; n=56	-2.5 Millimeter of mercury	Standard Deviation 11.61
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 18; n=19	-2.3 Millimeter of mercury	Standard Deviation 13.23
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 24; n=1	-19.0 Millimeter of mercury	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 48; n=56	-2.8 Millimeter of mercury	Standard Deviation 11.24
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 0; n=56	-1.2 Millimeter of mercury	Standard Deviation 14.48
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 2; n=56	-2.4 Millimeter of mercury	Standard Deviation 12.28
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	SBP; Week 6; n=55	-2.6 Millimeter of mercury	Standard Deviation 15.91
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 6; n=55	-1.4 Millimeter of mercury	Standard Deviation 13.08
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U	DBP; Week 12; n=53	-3.2 Millimeter of mercury	Standard Deviation 11.76

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 0; n=43	-0.11 Degree Celsius	Standard Deviation 0.429
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 2; n=43	-0.15 Degree Celsius	Standard Deviation 0.502
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 6; n=43	-0.04 Degree Celsius	Standard Deviation 0.53
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 12; n=40	-0.09 Degree Celsius	Standard Deviation 0.471
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 18; n=27	-0.18 Degree Celsius	Standard Deviation 0.481
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U	Week 48; n=43	-0.17 Degree Celsius	Standard Deviation 0.447

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 0; n=56	0.07 Degree Celsius	Standard Deviation 0.507
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 2; n=56	0.01 Degree Celsius	Standard Deviation 0.511
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 6; n=55	0.02 Degree Celsius	Standard Deviation 0.471
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 12; n=53	0.01 Degree Celsius	Standard Deviation 0.472
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 18; n=19	0.02 Degree Celsius	Standard Deviation 0.527
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 24; n=1	0.00 Degree Celsius	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U	Week 48; n=56	-0.04 Degree Celsius	Standard Deviation 0.5

Secondary

Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS3 Population comprised of all randomized participants who had at least 1 post-3rd treatment efficacy assessment after 3rd treatment.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=56,43	-2.99 Episodes	Standard Deviation 3.476
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=55,43	-3.53 Episodes	Standard Deviation 4.37
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=53,42	-3.43 Episodes	Standard Deviation 3.952
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=53,41	-3.50 Episodes	Standard Deviation 3.664
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=22,29	-3.09 Episodes	Standard Deviation 4.306
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=2,4	-2.00 Episodes	Standard Deviation 1.886
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=55,43	-4.57 Episodes	Standard Deviation 4.684
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=56,43	-3.92 Episodes	Standard Deviation 4.376
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=22,29	-3.80 Episodes	Standard Deviation 5.103
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=53,41	-4.60 Episodes	Standard Deviation 4.504
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=53,42	-5.10 Episodes	Standard Deviation 4.689
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=2,4	-0.83 Episodes	Standard Deviation 1.232

Secondary

Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Week 0; n=55,43	-1.8 Scores on a scale	Standard Deviation 1.93
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Week 12; n=54,42	-3.2 Scores on a scale	Standard Deviation 3.29
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Week 24;n=2,7	-2.0 Scores on a scale	Standard Deviation 2.83
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Week 0; n=55,43	-1.5 Scores on a scale	Standard Deviation 1.72
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Week 12; n=54,42	-2.6 Scores on a scale	Standard Deviation 2.89
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score	Week 24;n=2,7	-1.6 Scores on a scale	Standard Deviation 1.27

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U

Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U

Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U	2 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings

Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Time frame: Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 48; NCS; n=55,43	17 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 12; CS; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 48; CS; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 12; NCS; n=53,40	10 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 48; CS; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 12; CS; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 48; NCS; n=55,43	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings	Week 12; NCS; n=53,40	9 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U	Bladder ultrasound	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U	Kidney ultrasound	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U	Kidney ultrasound	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U	Bladder ultrasound	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; No change; n=53,42	29 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point improvement; n=56,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; No change; n=56,43	39 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point improvement; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point improvement; n=55,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point improvement; n=55,43	13 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; No change; n=55,43	37 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point improvement; n=53,42	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 2 point improvement; n=53,42	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point improvement; n=53,42	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point improvement; n=56,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point improvement; n=53,41	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point improvement; n=53,41	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; No change;n=53,41	36 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point improvement; n=22,29	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point improvement; n=22,29	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point improvement; n=22,29	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; No change; n=22,29	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point improvement; n=2,4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point improvement; n=2,4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point improvement; n=2,4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; No change;n=2,4	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point worsening; n=56,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point worsening; n=56,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point worsening; n=56,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point worsening; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point worsening; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point worsening; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point worsening; n=53, 42	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6;2 point worsening; n=53, 42	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point worsening; n=53, 42	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point worsening; n=53, 41	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point worsening; n=53, 41	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point worsening; n=53, 41	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point worsening; n=22, 29	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point worsening; n=22, 29	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point worsening; n=22, 29	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point worsening; n=2, 4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point worsening; n=2, 4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point worsening; n=2, 4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point improvement; n=56,43	13 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point improvement; n=53,41	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point worsening; n=56,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point worsening; n=2, 4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point improvement; n=56,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 1 point improvement; n=56,43	14 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 2 point worsening; n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; No change; n=56,43	26 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point worsening; n=22, 29	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point improvement; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point worsening; n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point improvement; n=55,43	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 0; 3 point improvement; n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point improvement; n=55,43	19 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 1 point worsening; n=55,43	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; No change; n=55,43	15 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point worsening; n=22, 29	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point improvement; n=53,42	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 2 point worsening; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 2 point improvement; n=53,42	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 1 point improvement; n=22,29	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point improvement; n=53,42	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 2; 3 point worsening; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; No change; n=53,42	22 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point worsening; n=22, 29	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point improvement; n=53,41	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 1 point worsening; n=53, 42	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point improvement; n=53,41	13 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point improvement; n=2,4	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6;2 point worsening; n=53, 42	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 3 point improvement; n=22,29	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 1 point worsening; n=2, 4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; 2 point improvement; n=22,29	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 6; 3 point worsening; n=53, 42	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point improvement; n=53,41	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 18; No change; n=22,29	18 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 1 point worsening; n=53, 41	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 3 point improvement; n=2,4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point worsening; n=2, 4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; 2 point improvement; n=2,4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 2 point worsening; n=53, 41	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; No change;n=53,41	20 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 24; No change;n=2,4	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline	Week 12; 3 point worsening; n=53, 41	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity

Time frame: Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 0; n=56,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 6; n=53,42	28 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 12; n=53,41	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 2; n=55,43	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 12; n=53,41	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 0; n=56,43	14 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 12; n=53,41	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 2; n=55,43	15 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 12; n=53,41	33 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 18; n=22,29	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 18; n=22,29	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 2; n=55,43	32 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 18; n=22,29	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 0; n=56,43	36 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 18; n=22,29	12 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 6; n=53,42	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 24; n=2,4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 0; n=56,43	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 24; n=2,4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 6; n=53,42	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 24; n=2,4	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 2; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 24; n=2,4	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 6; n=53,42	12 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 24; n=2,4	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 18; n=22,29	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 0; n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 0; n=56,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 0; n=56,43	16 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 0; n=56,43	25 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 2; n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 2; n=55,43	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 2; n=55,43	19 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 2; n=55,43	17 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 6; n=53,42	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 6; n=53,42	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 6; n=53,42	15 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 12; n=53,41	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 12; n=53,41	5 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 12; n=53,41	14 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 12; n=53,41	19 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 18; n=22,29	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 18; n=22,29	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 18; n=22,29	15 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	None; Week 24; n=2,4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Mild; Week 24; n=2,4	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Moderate; Week 24; n=2,4	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity	Severe; Week 6; n=53,42	19 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U	Any SAE	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U	Any non-SAE	19 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U	Any SAE	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U	Any non-SAE	22 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Normal or No Change; n=55,43	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To High; n=53,40	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Normal or No Change; n=55,43	55 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 48:Albumin; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Normal or No Change; n=53,40	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST;To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Normal or No Change; n=55,43	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To Normal or No Change; n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To Low; n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine;To Normal or NoChange; n=53,40	48 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To High; n=53,40	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Low; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST;To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Normal or No Change; n=55,43	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To Normal or No Change; n=53,40	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To High; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Low; n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Normal or No Change; n=53,40	45 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To Normal or No Change; n=55,43	55 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To High; n=53,40	6 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Normal or No Change; n=55,43	44 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid;To Normal or No Change; n=55,43	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To High; n=55,43	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp;To Normal or No Change;n=53,40	49 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium;To Normal or No Change; n=53,40	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil;To Normal or No Change;n=53,40	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Normal or No Change; n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To High; n=53,40	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To High; n=55,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium;To Normal or No Change; n=53,40	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Normal or No Change; n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium;To Normal or No Change; n=55,43	55 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 12:Albumin; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To Low; n=53,40	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil;To Normal or NoChange; n=53,40	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12: T Protein;To Normal or No Change;n=53,40	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To High; n=55,43	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To High; n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To Low; n=55,43	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid;To Normal or No Change;n=53,40	49 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein;To Normal or No Change; n=55,43	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Normal or No Change; n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12Urea/BUN; To Normal or No Change; n=53,40	49 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To Normal or No Change; n=53,40	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To High; n=53,40	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Normal or No Change; n=53,40	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Low; n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Normal or No Change; n=55,43	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Low; n=55,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To High; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Normal or No Change; n=53,40	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp;To Normal or No Change;n=55,43	50 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Uric acid; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid;To Normal or No Change; n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Uric acid; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 12:Albumin; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Albumin; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week 48:Albumin; To Low; n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To Normal or No Change; n=55,43	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Albumin; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Alk Phosp; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp;To Normal or No Change;n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Alk Phosp; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT;To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:ALT; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT;To Normal or No Change; n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:ALT; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST;To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To Normal or No Change; n=53,40	39 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:AST; To High; n=53,40	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST;To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To Normal or No Change; n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:AST; To High; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Direct Bil; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To Normal or No Change; n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Direct Bil; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To Low; n=53,40	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil;To Normal or NoChange; n=53,40	39 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Total Bil; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To Normal or No Change; n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Total Bil; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Calcium; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Low; n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To Normal or No Change; n=55,43	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Calcium; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Chloride; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To Normal or No Change; n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Chloride; To High; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine; To Low; n=53,40	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Creatinine;To Normal or NoChange; n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Creatinine; To Normal or No Change; n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To Normal or No Change; n=53,40	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Glucose; To High; n=53,40	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To Normal or No Change; n=55,43	32 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Glucose; To High; n=55,43	11 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To Low; n=53,40	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium;To Normal or No Change; n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Potassium; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To Normal or No Change; n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Potassium; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium;To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Sodium; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium;To Normal or No Change; n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Sodium; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To Low; n=53,40	7 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12: T Protein;To Normal or No Change;n=53,40	33 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:T Protein; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To Low; n=55,43	9 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein;To Normal or No Change; n=55,43	34 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:T Protein; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12Urea/BUN; To Normal or No Change; n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week12:Urea/BUN; To High; n=53,40	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To Normal or No Change; n=55,43	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results	Week48:Urea/BUN; To High; n=55,43	1 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hb; To Normal or No Change; n=53,40	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Monocytes; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb; To High; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes;To Normal or No Change;n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb;To Low;n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:N bands; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Normal or No Change;n=55,43	55 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands;To Normal or No Change;n=53,40	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To High; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands; To High; n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:N bands; To Low; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils; To High; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To Low; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands; To High; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands;To Normal or No Change;n=55,43	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hct;To Normal or No Change; n=53,40	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro;To Normal or No Change;n=53,40	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Eosino; To High; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To High; n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To Low; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino;To Normal or No Change;n=53,40	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro;To Normal or No Change;n=55,43	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count;To Normal or No Change;n=55,43	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:PC; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hct;To Normal or No Change; n=55,43	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:PC; To Normal or No Change; n=53,40	52 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: PC; To High;n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To High; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:PC; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino; To Low; n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:PC; To Normal or No Change; n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: PC; To High;n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino;To Normal or No Change;n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count; To Low;n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Lympho; To Normal or No Change; n=53,40	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To Normal or No Change;n=53,40	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Normal or No Change;n=53,40	53 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To High;n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count; To Low;n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To Low; n=55,43	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To Normal or No Change;n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Eosino; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To High;n=55,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Lympho; To Normal or No Change; n=55,43	51 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To Low;n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hb; To Normal or No Change; n=55,43	54 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count;To Normal or No Change;n=53,40	50 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb;To Low;n=53,40	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To High; n=53,40	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To Low;n=55,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To Low; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils; To High; n=53,40	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To High; n=55,43	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Monocytes;To Normal or No Change;n=53,40	53 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Basophils; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Normal or No Change;n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Eosino;To Normal or No Change;n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Eosino; To High; n=53,40	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Eosino;To Normal or No Change;n=55,43	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Eosino; To High; n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb;To Low;n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hb; To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12: Hb; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb;To Low;n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hb; To Normal or No Change; n=55,43	39 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48: Hb; To High; n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: Hct;To Normal or No Change; n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Hct; To High; n=53,40	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: Hct;To Normal or No Change; n=55,43	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Hct; To High; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Lympho; To Low; n=53,40	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Lympho; To Normal or No Change; n=53,40	39 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Lympho; To Normal or No Change; n=55,43	41 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Lympho; To High; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:Monocytes;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:Monocytes; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:Monocytes; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes;To Normal or No Change;n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Monocytes; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:N bands; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:N bands; To High; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:N bands; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands;To Normal or No Change;n=55,43	43 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:N bands; To High; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To Low; n=53,40	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro;To Normal or No Change;n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:T Neutro; To High; n=53,40	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To Low; n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro;To Normal or No Change;n=55,43	39 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:T Neutro; To High; n=55,43	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:PC; To Low; n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 12:PC; To Normal or No Change; n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12: PC; To High;n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:PC; To Low; n=55,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week 48:PC; To Normal or No Change; n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48: PC; To High;n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count; To Low;n=53,40	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To Normal or No Change;n=53,40	38 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:RBC count;To High;n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count; To Low;n=55,43	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To Normal or No Change;n=55,43	37 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:RBC count;To High;n=55,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count; To Low;n=53,40	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week12:WBC count;To Normal or No Change;n=53,40	40 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count; To Low;n=55,43	1 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:WBC count;To Normal or No Change;n=55,43	42 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters	Week48:Basophils;To Low; n=55,43	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 3.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U	14 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 100 U

A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.

Time frame: Up to 48 weeks after 1st treatment

Population: Safety Population 2.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 100 U	15 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline

Time frame: Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; No Change/Decreased, n=56,43	40 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Any Increase, n=56,43	16 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to Traces, n=56,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 1+, n=56,43	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 2+, n=56,43	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 3+, n=56,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 4+, n=56,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;No Change/Decreased, n=56,43	44 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;Any Increase, n=56,43	12 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to Traces, n=56,43	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 1+, n=56,43	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 2+, n=56,43	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 3+, n=56,43	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 4+, n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 1+, n=56,43	2 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; No Change/Decreased, n=56,43	25 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;No Change/Decreased, n=56,43	37 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Any Increase, n=56,43	18 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 3+, n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to Traces, n=56,43	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein;Any Increase, n=56,43	6 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 1+, n=56,43	8 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 2+, n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 2+, n=56,43	3 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to Traces, n=56,43	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 3+, n=56,43	4 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Protein; Increase to 4+, n=56,43	0 Participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline	Occult Blood; Increase to 4+, n=56,43	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition

The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=22,29	20.23 Percent change	Standard Deviation 45.654
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=55,43	20.24 Percent change	Standard Deviation 37.34
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=53,41	25.51 Percent change	Standard Deviation 37.686
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=2,4	-3.88 Percent change	Standard Deviation 0.051
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=53,41	25.28 Percent change	Standard Deviation 40.894
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=56,43	18.96 Percent change	Standard Deviation 37.442
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 24; n=2,4	11.46 Percent change	Standard Deviation 36.629
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 2; n=55,43	25.78 Percent change	Standard Deviation 43.344
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 12; n=53,41	20.05 Percent change	Standard Deviation 40.347
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 18; n=22,29	19.37 Percent change	Standard Deviation 34.051
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 0; n=56,43	23.41 Percent change	Standard Deviation 33.357
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition	Week 6; n=53,41	23.65 Percent change	Standard Deviation 46.594

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes

The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=53,42	-36.80 Percent change	Standard Deviation 45.867
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=2,4	-18.69 Percent change	Standard Deviation 11.796
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=53,41	-33.95 Percent change	Standard Deviation 35.729
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=55,43	-31.32 Percent change	Standard Deviation 58.36
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=22,29	-28.72 Percent change	Standard Deviation 37.453
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=56,43	-25.28 Percent change	Standard Deviation 38.08
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 12; n=53,41	-32.80 Percent change	Standard Deviation 62.144
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 0; n=56,43	-21.29 Percent change	Standard Deviation 56.917
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 6; n=53,42	-36.67 Percent change	Standard Deviation 60.41
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 18; n=22,29	-33.32 Percent change	Standard Deviation 47.86
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 24; n=2,4	-18.03 Percent change	Standard Deviation 21.046
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes	Week 2; n=55,43	-35.08 Percent change	Standard Deviation 55.559

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=56,43	-37.29 Percent change	Standard Deviation 46.169
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=55,43	-48.51 Percent change	Standard Deviation 63.535
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=53,42	-52.66 Percent change	Standard Deviation 54.383
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=53,41	-53.49 Percent change	Standard Deviation 43.246
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=22,29	-39.80 Percent change	Standard Deviation 45.118
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=2,4	-16.85 Percent change	Standard Deviation 14.397
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 18; n=22,29	-44.10 Percent change	Standard Deviation 43.035
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 0; n=56,43	-41.20 Percent change	Standard Deviation 30.656
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 12; n=53,41	-54.62 Percent change	Standard Deviation 33.369
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 2; n=55,43	-54.46 Percent change	Standard Deviation 44.164
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 24; n=2,4	-29.06 Percent change	Standard Deviation 37.514
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes	Week 6; n=53,42	-60.40 Percent change	Standard Deviation 35.855

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=55,43	-49.97 Percent change	Standard Deviation 61.305
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=56,43	-35.51 Percent change	Standard Deviation 47.233
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=53,42	-54.12 Percent change	Standard Deviation 48.948
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=53,41	-54.34 Percent change	Standard Deviation 44.946
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=22,29	-37.88 Percent change	Standard Deviation 49.474
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=2,4	-18.69 Percent change	Standard Deviation 11.796
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 18; n=22,29	-44.81 Percent change	Standard Deviation 45.494
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 12; n=53,41	-55.10 Percent change	Standard Deviation 36.963
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 0; n=56,43	-35.41 Percent change	Standard Deviation 40.461
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 2; n=55,43	-53.60 Percent change	Standard Deviation 53.462
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 24; n=2,4	-34.56 Percent change	Standard Deviation 31.169
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes	Week 6; n=53,42	-53.99 Percent change	Standard Deviation 48.401

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids

The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 0; n=56,43	-9.68 Percent change	Standard Deviation 30.804
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 2; n=55,43	-9.81 Percent change	Standard Deviation 30.062
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 6; n=53,42	-12.53 Percent change	Standard Deviation 25.204
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 12; n=53,41	-13.16 Percent change	Standard Deviation 23.767
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 18; n=22,29	-11.60 Percent change	Standard Deviation 32.168
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 24; n=2,4	-12.42 Percent change	Standard Deviation 8.142
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 6; n=53,42	-19.34 Percent change	Standard Deviation 20.321
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 0; n=56,43	-14.43 Percent change	Standard Deviation 19.179
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 18; n=22,29	-13.31 Percent change	Standard Deviation 18.08
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 24; n=2,4	-9.07 Percent change	Standard Deviation 5.887
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 2; n=55,43	-15.98 Percent change	Standard Deviation 22.524
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids	Week 12; n=53,41	-15.30 Percent change	Standard Deviation 17.431

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes

Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=21,26	-2.77 Percent change	Standard Deviation 66.95
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=54,38	-10.30 Percent change	Standard Deviation 56.988
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=51,37	-17.59 Percent change	Standard Deviation 58.516
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=53,38	-12.65 Percent change	Standard Deviation 56.372
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=2,4	50.00 Percent change	Standard Deviation 70.711
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=51,37	-10.34 Percent change	Standard Deviation 58.618
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 24; n=2,4	16.73 Percent change	Standard Deviation 128.469
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 12; n=51,37	-23.85 Percent change	Standard Deviation 69.048
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 18; n=21,26	-13.64 Percent change	Standard Deviation 71.573
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 6; n=51,37	-15.84 Percent change	Standard Deviation 67.482
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 0; n=54,38	-12.92 Percent change	Standard Deviation 66.778
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes	Week 2; n=53,38	-17.41 Percent change	Standard Deviation 72.146

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=50%; n=53,41	62 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=75%; n=56,43	21 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=50%; n=56,43	50 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; 100 %; n=55,43	13 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=75%; n=55,43	36 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=50%; n=55,43	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; 100 %; n=53,42	13 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=75%; n=53,42	43 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=50%; n=53,42	70 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; 100 %; n=53,41	13 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=75%; n=53,41	45 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; 100 %; n=22,29	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=75%; n=22,29	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=50%; n=22,29	50 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; 100 %; n=2,4	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=75%; n=2,4	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=50%; n=2,4	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; 100%; n=56,43	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=50%; n=2,4	50 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; 100%; n=56,43	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; 100 %; n=53,41	10 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=75%; n=56,43	7 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=50%; n=22,29	55 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 0; >=50%; n=56,43	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=75%; n=53,41	34 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; 100 %; n=55,43	16 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 12; >=50%; n=53,41	54 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=75%; n=55,43	42 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; >=75%; n=2,4	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 2; >=50%; n=55,43	58 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; 100 %; n=22,29	3 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; 100 %; n=53,42	12 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 24; 100 %; n=2,4	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=75%; n=53,42	43 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 18; >=75%; n=22,29	34 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes	Week 6; >=50%; n=53,42	76 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes

Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.

Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; 100%; n=56,43	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=75%; n=56,43	21 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=75%; n=55,43	35 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=50%; n=55,43	67 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; 100 %; n=53,42	15 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=75%; n=53,42	47 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; 100 %; n=53,41	15 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=75%; n=53,41	47 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=50%; n=53,41	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; 100 %; n=22,29	18 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=75%; n=22,29	23 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=50%; n=22,29	55 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=75%; n=2,4	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=50%; n=2,4	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=50%; n=56,43	48 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; 100 %; n=55,43	16 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=50%; n=53,42	68 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; 100 %; n=2,4	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; 100 %; n=2,4	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; 100%; n=56,43	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=50%; n=53,41	59 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=75%; n=56,43	7 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 0; >=50%; n=56,43	40 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; 100 %; n=55,43	19 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=50%; n=2,4	50 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=75%; n=55,43	42 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; 100 %; n=22,29	3 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 2; >=50%; n=55,43	60 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 24; >=75%; n=2,4	0 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; 100 %; n=53,42	14 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=75%; n=22,29	38 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=75%; n=53,42	43 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 6; >=50%; n=53,42	69 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; 100 %; n=53,41	12 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 18; >=50%; n=22,29	59 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes	Week 12; >=75%; n=53,41	37 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS

Time frame: Week 0, Week 2, Week 6, Week 12 and Week 24 in Treatment Cycle 3

Population: FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 2; n=56,43	64 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 12; n=54,42	63 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 6; n=55,43	65 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 24; n=2,7	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 0; n=56,43	61 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 24; n=2,7	29 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 0; n=56,43	49 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 2; n=56,43	60 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 6; n=55,43	63 Percentage of participants
Treatment Cycle 1: GSK1358820 100 U	Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS	Week 12; n=54,42	55 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026

Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder

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Study design

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Exclusion criteria

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Primary

Secondary

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Participant flow

Recruitment details

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Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature

Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment

Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score

Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)

Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids

Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes

Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)

Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment

Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes

Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U