Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02849418

Enrollment

Registered

2016-07-29

Start date

2016-10-11

Completion date

2018-12-20

Last updated

2021-07-14

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

Conditions

Urinary Bladder, Overactive

Keywords

Botulinum toxin type A, Urinary Incontinence, Neurogenic Detrusor Overactivity

Brief summary

This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not been adequately managed with medications for urinary incontinence due to NDO. This study consists of a screening phase up to 28 days followed by a double-blind Treatment phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since the previous treatment. The duration of overall treatment phases is 48 weeks. The total duration of participation for any subject will not exceed 52 weeks, including screening.

Interventions

DRUGGSK1358820

GSK1358820 injection contains botulinum toxin type A (100 U), sodium chloride (0.9 milligrams \[mg\]), and human serum albumin (0.5 mg). The 30 mL of study drug will be administered as 30 injections each of 1.0 mL, evenly distributed at 30 sites in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered using cystoscopy and under local anesthesia. General anesthesia may be used excluding neuromuscular blocking agents.

DRUGPlacebo

Placebo injection contains sodium chloride (0.9 milligrams \[mg\]); 30 mL of the injection will be injected at 30 sites in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered using cystoscopy and under local anesthesia. General anesthesia may be used excluding neuromuscular blocking agents

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 urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented subject history. In addition: 1. Spinal cord injury subjects must have a stable neurological injury level C5 or below occurring \>=6 months prior to screening. 2. Multiple sclerosis subjects must be clinically stable in the investigator's opinion, for \>=3 months prior to screening and have an Expanded Disability Status Scale score \<=6.5 * Subject has NDO for a period of at least 3 months prior to screening, determined by documented subject history. The presence of an involuntary detrusor contractions (IDC) must also be demonstrated during the urodynamic assessment during the screening period or Day 1 (prior to randomization). * Subject has not been adequately managed with one or more medications (i.e., anticholinergics or beta-3 adrenergic receptor agonist) for treatment of urinary incontinence due to NDO . Not adequately managed is defined as: An inadequate response after at least a 4-week period of medication(s) for urinary incontinence due to NDO on an optimized dose(s), i.e., subject is still incontinent despite medication(s) for urinary incontinence due to NDO, or Limiting side effects (i.e., condition that subject reduced dosage or discontinued the medication due to side effect) after at least a 2-week period of medication(s) for urinary incontinence due to NDO on an optimized dose(s) * Subject has \>=6 episodes of urinary incontinence, with no more than one urgency incontinence-free day in the 3-day subject bladder diary completed during the screening phase * Subject currently uses or is willing to use clean intermittent catheterization (CIC) to empty the bladder (indwelling catheter is not permitted). Subjects currently on CIC should be willing to maintain a CIC schedule of at least 3 times per day throughout the study. Caregiver may perform CIC. * Body weight \>=40 kilogram (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 following the contraceptive options: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 (e.g., 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 a history or evidence of any diseases, functional abnormalities or bladder surgery, other than NDO, 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 discontinued at least 7 days prior to the start of the screening phase 4. Current use of a baclofen pump 5. History of interstitial cystitis, in the opinion of the investigator (or subinvestigator) 6. 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) 7. 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. 8. An active genital infection, other than genital warts, either concurrently or within 4 weeks prior to Screening 9. Male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of \>10 nanogram (ng)/milliliter (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. 10. Evidence of urethral and/or bladder outlet obstruction, in the opinion of the investigator (or subinvestigator) * Subject has a serum creatinine level \>2 times the upper limit of normal (ULN) at screening * Alanine aminotransferase (ALT) \> 2×ULN; and bilirubin \> 1.5×ULN (isolated bilirubin \>1.5×ULN 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, hypoalbuminaemia, oesophageal 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 * QTc \>450 milliseconds (msec) or QTc \>480 msec in subjects with Bundle Branch Block from the result of 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 changes or initiates or discontinues anticholinergic, beta-3 adrenergic receptor agonist or any other medications or therapies to treat urinary incontinence due to NDO, within 6 days prior to the start of the screening phase * Subject has been treated with any intravesical pharmacologic agent (e.g., capsaicin, resiniferatoxin) for urinary incontinence due to NDO 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 without a urinary tract infection (UTI) as determined from the urinalysis or urine culture and/or investigator opinion, has not initiated prophylactic antibiotic medication 1 to 3 days prior to the initiation of Treatment phase 1 (Week 0). Subject with a UTI as determined from the urinalysis or urine culture and/or investigator opinion, has not initiated antibiotic medication at least 5 days prior to the initiation of Treatment phase 1 (Week 0) * Subject is symptomatic for UTI on day of treatment * 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 post void residual urine volume above 200 mL for subjects who micturate or have a mixed catheterization/spontaneous micturition pattern. The post void residual measurement can be repeated once; the subject is to be excluded if the repeated measure is above 200 mL. * 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 sub-investigator'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 6	Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Secondary

Measure	Time frame	Description
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6	Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1	PmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6	Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1	VPmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6	Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1	PdetMax was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Baseline (Day 1, 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS2 comprised all randomized participants who had at least 1 post-second treatment efficacy assessment after the second treatment.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS3 comprised all randomized participants who had at least 1 post-third treatment efficacy assessment after the third treatment.
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the 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 on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Baseline (Day 1, 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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 the 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	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Baseline (Day 1, 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the 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	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- Percent Change From Baseline in the Daily Average Number of Voids	Baseline (Day 1, 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- Percent Change From Baseline in the Daily Average Number of Voids	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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 over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Baseline (Day 1, 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 over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Percent 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 over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- Percent Change From Baseline in Average Volume Voided Per Micturition	Baseline (Day 1, 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 over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- Percent Change From Baseline in Average Volume Voided Per Micturition	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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)- 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 1 have been presented.
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 (Day 1, 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 the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 2 have been presented.
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 (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3	Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 3 have been presented.
Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment	Up to 36 Weeks in Treatment Cycle 1	Participants can be 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 at least 4 episodes of urinary incontinence, with no more than one incontinence-free day, post-void residual (PVR) urine volume must have been \<200 mL for participants who micturated or had a mixed catheterization / spontaneous micturition pattern, body weight \>=40 kilogram; 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 gave Yes response to the question of participants qualification for retreatment minus the day of first treatment plus 1.
Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment	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 provided Yes response to the question of participants request for 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 Score	Baseline (Pre-dose on Day 1), Week 6, 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 or energy (S or E) (1\[Never\] to 4\[All the time\]) and Severity or Coping (S or 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 or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or 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 Score	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, 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 or E (1\[Never\] to 4\[All the time\]) and S or 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 or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or 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 Score	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, 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 or E (1\[Never\] to 4\[All the time\]) and S or 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 or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or 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 Treatment Benefit Scale (TBS)	Week 2, Week 6 , Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1	TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.
Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 0, Week 2, Week 6, Week 12, Week 24, and Week 36 in Treatment Cycle 2	TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.
Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 0, Week 2, Week 6, Week 12, and Week 24 in Treatment Cycle 3	TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE	Up to Week 48 in Treatment Cycle 1	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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U	Up to 48 weeks after 1st treatment	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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. 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 200 U / GSK1358820 200 U	Up to 48 weeks after 1st treatment	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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. 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 200 U	Up to 48 weeks after 1st treatment	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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U	Up to 48 weeks after 1st treatment	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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. Safety Population 3 comprised of all participants who received 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 24, Week 36 and Week 48 in Treatment Cycle 1	Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1	Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1	Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2	Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3	Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	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, 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. Only categories with non-zero values have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	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, Eosinophils, 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. Only categories with non-zero values have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	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, Eosinophils, 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. Only categories with non-zero values have been presented.
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	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. Only categories with non-zero values have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	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. Only categories with non-zero values have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	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. Only categories with non-zero values have been presented.
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Baseline (Pre-dose on Day 1) and up to Week 48 in Treatment Cycle 1	Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Baseline (Day 1, pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment	Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Baseline (Day 1, pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment	Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Urinary Tract Infection (UTI)	Up to Week 48 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 200 U	Up to Week 48 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.
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 24, Week 36 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1	PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both clean intermittent catheterization \[CIC\] and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. For participants who had a PVR urine volume measurement repeated, only the repeat value was recorded. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2	PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2	PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3	PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3	PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.
Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR	Up to Week 48 in Treatment Cycle 1	CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. 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 200 U	Up to 48 weeks after 1st treatment	CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. 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 200 U / GSK1358820 200 U	Up to 48 weeks after 1st treatment	CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. 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)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6	Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1	MCC was calculated by urodynamic assessment according to International Continence Society (ICS) standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U	Up to 48 weeks after 1st treatment	CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. 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 in Kidney and Bladder Ultrasound Examination	Up to Week 48 in Treatment Cycle 1	The kidney and bladder ultrasound study was performed according to the study schedule. 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 were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound study was performed according to the study schedule. 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 were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound study was performed according to the study schedule. 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 were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U	Up to 48 weeks after 1st treatment	The kidney and bladder ultrasound study was performed according to the study schedule. 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 were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U	Up to 48 weeks after 1st treatment	CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. 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 Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) 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 each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS 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 each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS 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 each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U	Up to 48 weeks after 1st treatment	CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.

Countries

Japan

Participant flow

Recruitment details

This study evaluated the efficacy and safety of GSK1358820 (botulinum toxin type A) in participants with urinary incontinence due to neurogenic detrusor overactivity. This was a multicenter study conducted at 7 centers in Japan.

Pre-assignment details

A total of 30 participants were screened of which 21 participants were randomized (11 participants in the GSK1358820 200 Unit \[U\] group and 10 participants in the placebo group).

Participants by arm

Arm	Count
Placebo Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met retreatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 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.	10
GSK1358820 200U Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met retreatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 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.	11
Total	21

Baseline characteristics

Characteristic	Placebo	GSK1358820 200U	Total
Age, Continuous	47.2 Years STANDARD_DEVIATION 18.29	50.9 Years STANDARD_DEVIATION 14.12	49.1 Years STANDARD_DEVIATION 15.93
Race/Ethnicity, Customized Asian - Japanese/East Asian (EA)/South EA Heritage	10 Participants	11 Participants	21 Participants
Sex: Female, Male Female	1 Participants	3 Participants	4 Participants
Sex: Female, Male Male	9 Participants	8 Participants	17 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 / 10	0 / 11	0 / 10	0 / 6	0 / 5	0 / 3
other Total, other adverse events	5 / 10	8 / 11	5 / 10	5 / 6	4 / 5	3 / 3
serious Total, serious adverse events	1 / 10	1 / 11	1 / 10	0 / 6	0 / 5	0 / 3

Outcome results

Primary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 6

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Adjusted mean and standard error of adjusted mean has been reported.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Population: FAS1 Population

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 6	-0.18 Episodes	Standard Error 0.957
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 6	-3.20 Episodes	Standard Error 0.911

95% CI: [-5.85, -0.19]

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 over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the 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. Only those participants with data available at the specified time points were analyzed.

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 12	6.85 Milliliter	Standard Deviation 77.905
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 30	165.22 Milliliter	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 6	0.98 Milliliter	Standard Deviation 86.368
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 18	55.19 Milliliter	Standard Deviation 44.989
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 24	53.65 Milliliter	Standard Deviation 72.444
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 2	-3.68 Milliliter	Standard Deviation 55.395
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 30	66.37 Milliliter	Standard Deviation 48.478
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 36	70.07 Milliliter	Standard Deviation 26.988
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 42	80.47 Milliliter	Standard Deviation 42.477
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 48	59.98 Milliliter	Standard Deviation 6.616
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 2	61.12 Milliliter	Standard Deviation 50.47
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 12	69.98 Milliliter	Standard Deviation 64.01
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 18	84.11 Milliliter	Standard Deviation 74.478
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 6	107.53 Milliliter	Standard Deviation 79.483
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition	Week 24	82.77 Milliliter	Standard Deviation 61.992

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature

Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 24	0.30 Degree Celsius	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 12	0.14 Degree Celsius	Standard Deviation 0.46
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 6	0.05 Degree Celsius	Standard Deviation 0.375
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 2	0.29 Degree Celsius	Standard Deviation 0.438
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 24	-0.22 Degree Celsius	Standard Deviation 0.471
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 36	-0.25 Degree Celsius	Standard Deviation 0.55
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 48	-0.20 Degree Celsius	Standard Deviation 0.4
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 2	-0.06 Degree Celsius	Standard Deviation 0.391
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 6	-0.15 Degree Celsius	Standard Deviation 0.401
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature	Week 12	0.03 Degree Celsius	Standard Deviation 0.535

Secondary

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

Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 24	-10.0 Beats per minute	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 2	-1.3 Beats per minute	Standard Deviation 14.28
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 6	1.7 Beats per minute	Standard Deviation 12.64
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 12	-1.4 Beats per minute	Standard Deviation 9.96
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 2	-1.0 Beats per minute	Standard Deviation 10.8
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 12	3.1 Beats per minute	Standard Deviation 6.01
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 6	4.5 Beats per minute	Standard Deviation 15.21
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 36	0.2 Beats per minute	Standard Deviation 12.86
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 48	-13.0 Beats per minute	Standard Deviation 7.48
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate	Week 24	-9.3 Beats per minute	Standard Deviation 9.79

Secondary

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

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 or energy (S or E) (1\[Never\] to 4\[All the time\]) and Severity or Coping (S or 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 or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or 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 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1

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

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 Score	General Health Perception, Week 36	25.0 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 24	-25.00 Scores on a scale	Standard Deviation 58.926
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 6	-16.67 Scores on a scale	Standard Deviation 22.981
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 6	3.33 Scores on a scale	Standard Deviation 27.242
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 12	-24.44 Scores on a scale	Standard Deviation 18.739
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 6	-6.67 Scores on a scale	Standard Deviation 21.082
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 24	-22.22 Scores on a scale	Standard Deviation 15.713
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 36	-83.33 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 36	0.00 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 12	-3.33 Scores on a scale	Standard Deviation 33.148
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 6	-10.42 Scores on a scale	Standard Deviation 21.708
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 12	-3.33 Scores on a scale	Standard Deviation 24.595
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 24	-16.67 Scores on a scale	Standard Deviation 23.57
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 6	-9.33 Scores on a scale	Standard Deviation 8.999
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 36	-33.33 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 12	-14.00 Scores on a scale	Standard Deviation 15.854
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 24	0.00 Scores on a scale	Standard Deviation 31.427
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 12	4.17 Scores on a scale	Standard Deviation 45.207
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 36	11.11 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 6	-21.67 Scores on a scale	Standard Deviation 20.861
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health perception, Week 6	12.5 Scores on a scale	Standard Deviation 13.18
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 6	-10.00 Scores on a scale	Standard Deviation 23.831
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 12	-13.33 Scores on a scale	Standard Deviation 29.187
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 12	-11.67 Scores on a scale	Standard Deviation 20.861
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 24	0.00 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 24	8.33 Scores on a scale	Standard Deviation 11.785
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 24	-16.67 Scores on a scale	Standard Deviation 23.57
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 36	0.00 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health Perception, Week 12	2.5 Scores on a scale	Standard Deviation 18.45
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 36	-33.33 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 36	0.00 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health Perception, Week 24	12.5 Scores on a scale	Standard Deviation 17.68
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 24	-6.67 Scores on a scale	Standard Deviation 18.856
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 36	0.00 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 6	-20.00 Scores on a scale	Standard Deviation 18.922
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 12	-20.00 Scores on a scale	Standard Deviation 24.595
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 6	-7.58 Scores on a scale	Standard Deviation 36.027
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 12	-9.09 Scores on a scale	Standard Deviation 35.248
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 24	-18.75 Scores on a scale	Standard Deviation 35.003
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 36	-16.67 Scores on a scale	Standard Deviation 27.889
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Sleep/energy, Week 48	-0.00 Scores on a scale	Standard Deviation 23.57
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 6	-10.30 Scores on a scale	Standard Deviation 20.519
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 12	-14.55 Scores on a scale	Standard Deviation 18.355
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 36	-15.56 Scores on a scale	Standard Deviation 17.213
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health Perception, Week 24	0.0 Scores on a scale	Standard Deviation 13.36
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 48	-6.67 Scores on a scale	Standard Deviation 13.333
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 6	-4.55 Scores on a scale	Standard Deviation 44.778
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 12	-15.15 Scores on a scale	Standard Deviation 37.605
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 36	-22.22 Scores on a scale	Standard Deviation 32.773
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 48	-0.00 Scores on a scale	Standard Deviation 27.217
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 36	6.67 Scores on a scale	Standard Deviation 14.907
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 6	-9.09 Scores on a scale	Standard Deviation 22.672
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Severity/Coping measures, Week 24	-15.83 Scores on a scale	Standard Deviation 23.077
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health perception, Week 6	6.8 Scores on a scale	Standard Deviation 25.23
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health Perception, Week 12	9.1 Scores on a scale	Standard Deviation 12.61
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health Perception, Week 36	16.7 Scores on a scale	Standard Deviation 12.91
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	General Health Perception, Week 48	15.0 Scores on a scale	Standard Deviation 13.69
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 6	-30.30 Scores on a scale	Standard Deviation 43.345
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 12	-30.30 Scores on a scale	Standard Deviation 40.701
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 24	-29.17 Scores on a scale	Standard Deviation 33.034
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 36	-38.89 Scores on a scale	Standard Deviation 38.968
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Incontinence impact, Week 48	-26.67 Scores on a scale	Standard Deviation 36.515
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 6	-12.12 Scores on a scale	Standard Deviation 27.979
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 12	-12.12 Scores on a scale	Standard Deviation 27.979
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 24	-25.00 Scores on a scale	Standard Deviation 30.861
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 36	-27.78 Scores on a scale	Standard Deviation 25.092
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Role Limitations, Week 48	-10.00 Scores on a scale	Standard Deviation 14.907
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 24	-27.08 Scores on a scale	Standard Deviation 34.431
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Physical Limitations, Week 48	-6.67 Scores on a scale	Standard Deviation 9.129
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 6	-7.07 Scores on a scale	Standard Deviation 47.212
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 12	-2.02 Scores on a scale	Standard Deviation 41.52
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 24	-25.00 Scores on a scale	Standard Deviation 43.946
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Social Limitations, Week 36	-11.11 Scores on a scale	Standard Deviation 54.433
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 6	12.50 Scores on a scale	Standard Deviation 38.576
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 12	-4.17 Scores on a scale	Standard Deviation 19.416
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 24	2.38 Scores on a scale	Standard Deviation 17.817
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Personal Relationships, Week 48	8.33 Scores on a scale	Standard Deviation 28.868
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 12	-8.08 Scores on a scale	Standard Deviation 24.89
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 24	-19.44 Scores on a scale	Standard Deviation 23.57
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 36	-16.67 Scores on a scale	Standard Deviation 29.606
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score	Emotions, Week 48	-17.78 Scores on a scale	Standard Deviation 18.592

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6

MCC was calculated by urodynamic assessment according to International Continence Society (ICS) standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Population: FAS1 Population

Arm	Measure	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6	62.05 Milliliter	Standard Deviation 104.783
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6	157.09 Milliliter	Standard Deviation 161.159

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6

PmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

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

Arm	Measure	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6	-0.005 Centimeter of water (cmH2O)	Standard Deviation 15.1414
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6	-21.000 Centimeter of water (cmH2O)	Standard Deviation 27.7705

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6

PdetMax was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Population: FAS1 Population

Arm	Measure	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6	-13.72 cmH2O	Standard Deviation 29.141
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6	-31.18 cmH2O	Standard Deviation 28.067

Secondary

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

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both clean intermittent catheterization \[CIC\] and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. For participants who had a PVR urine volume measurement repeated, only the repeat value was recorded. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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	6.25 Milliliter	Standard Deviation 8.839
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 6	25.33 Milliliter	Standard Deviation 22.143
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 12	-30.73 Milliliter	Standard Deviation 47.963
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 24	24.00 Milliliter	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 12	177.03 Milliliter	Standard Deviation 245.67
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 2	166.50 Milliliter	Standard Deviation 244.34
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 24	208.85 Milliliter	Standard Deviation 45.891
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 36	206.65 Milliliter	Standard Deviation 196.081
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 6	87.00 Milliliter	Standard Deviation 175.997
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume	Week 48	207.10 Milliliter	Standard Deviation 231.648

Secondary

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

Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.

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

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

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 24	-15.0 Millimeters of mercury	—
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	1.7 Millimeters of mercury	Standard Deviation 8.78
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	1.9 Millimeters of mercury	Standard Deviation 11.87
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	-0.4 Millimeters of mercury	Standard Deviation 8.1
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	-9.0 Millimeters of mercury	—
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	0.0 Millimeters of mercury	Standard Deviation 16.31
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	1.4 Millimeters of mercury	Standard Deviation 13.94
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	-1.8 Millimeters of mercury	Standard Deviation 9.15
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP, Week 6	4.6 Millimeters of mercury	Standard Deviation 9.2
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP, Week 24	3.3 Millimeters of mercury	Standard Deviation 8.8
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP, Week 36	3.2 Millimeters of mercury	Standard Deviation 5.15
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP, Week 12	6.2 Millimeters of mercury	Standard Deviation 20.76
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP, Week 48	1.6 Millimeters of mercury	Standard Deviation 6.91
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP, Week 12	1.7 Millimeters of mercury	Standard Deviation 12.45
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP, Week 2	7.3 Millimeters of mercury	Standard Deviation 11.24
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP, Week 6	7.4 Millimeters of mercury	Standard Deviation 14.6
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP, Week 24	11.6 Millimeters of mercury	Standard Deviation 12.87
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP, Week 36	2.7 Millimeters of mercury	Standard Deviation 9.71
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	SBP, Week 48	7.4 Millimeters of mercury	Standard Deviation 16.58
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	DBP, Week 2	1.5 Millimeters of mercury	Standard Deviation 9.77

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number 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 the specified time points were analyzed.

Arm	Measure	Group	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	Week 24	-2.50 Episodes	Standard Deviation 2.593
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-0.90 Episodes	Standard Deviation 2.658
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-0.27 Episodes	Standard Deviation 3.321
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-0.40 Episodes	Standard Deviation 2.459
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-2.33 Episodes	Standard Deviation 0.943
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 30	-3.33 Episodes	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-2.82 Episodes	Standard Deviation 2.518
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 42	-3.47 Episodes	Standard Deviation 2.181
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-3.46 Episodes	Standard Deviation 2.513
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-3.79 Episodes	Standard Deviation 2.295
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 48	-3.80 Episodes	Standard Deviation 2.008
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-2.67 Episodes	Standard Deviation 2.53
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 30	-3.42 Episodes	Standard Deviation 2.195
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-3.12 Episodes	Standard Deviation 2.469
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 36	-3.94 Episodes	Standard Deviation 2.832

Secondary

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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the 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. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 24	-1.83 Voids	Standard Deviation 0.707
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 12	0.37 Voids	Standard Deviation 1.869
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 30	-3.00 Voids	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 6	0.10 Voids	Standard Deviation 1.406
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 18	-0.83 Voids	Standard Deviation 1.65
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 2	-0.15 Voids	Standard Deviation 1.253
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 36	-2.83 Voids	Standard Deviation 3.698
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 42	-2.20 Voids	Standard Deviation 3.024
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 30	-2.54 Voids	Standard Deviation 3.616
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 48	-2.47 Voids	Standard Deviation 3.548
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 2	-0.79 Voids	Standard Deviation 1.905
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 6	-2.15 Voids	Standard Deviation 3.354
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 12	-2.24 Voids	Standard Deviation 3.742
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 18	-3.04 Voids	Standard Deviation 3.827
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids	Week 24	-2.88 Voids	Standard Deviation 3.788

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6

VPmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1

Population: FAS1 Population

Arm	Measure	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6	67.7 Milliliter	Standard Deviation 68.28
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6	188.9 Milliliter	Standard Deviation 157.43

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR

CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. 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 Week 48 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 CIC for Urinary Retention or Elevated PVR	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR	1 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination

The kidney and bladder ultrasound study was performed according to the study schedule. 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 were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.

Time frame: Up to Week 48 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 Abnormal Findings in Kidney and Bladder Ultrasound Examination	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination	0 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings

Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.

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 the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Week 12: A-NCS	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Week 12: ACS	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Baseline: A-NCS	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Baseline: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Week 48: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Baseline: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Baseline: A-NCS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Week 12: A-NCS	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Week 12: ACS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings	Week 48: A-NCS	1 Participants

Secondary

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

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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.

Time frame: Up to Week 48 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 Serious Adverse Events (SAEs) and Non-SAE	SAEs	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE	Non-SAEs	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE	SAEs	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE	Non-SAEs	8 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

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. Only categories with non-zero values have been presented.

Time frame: Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, High	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Potassium, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Albumin, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Sodium, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Albumin, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein, Normal or no change	4 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Normal or no change	4 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Albumin, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Albumin, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Albumin, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Direct Bil, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Total Bil, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, Normal or no change	7 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, High	4 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Potassium, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Potassium, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Sodium, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Sodium, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein, Low	1 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, 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. Only categories with non-zero values have been presented.

Time frame: Week 12, and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1

Population: SPDB Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Hct, Normal or No change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Basophils, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:RBC count, Normal or no change	10 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:WBC count, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Normal to no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: Hb,Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Monocytes, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: N bands, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:RBC count, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Normal to no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hb, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hct, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48:T neutro, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:WBC count, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:WBC count, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Basophils, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Basophils, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Eosinophils, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: Hb,Normal or no change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Hct, Normal or No change	11 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Normal or no change	10 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Lympho, Normal or no change	5 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to Week 48 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)	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Urinary Tract Infection (UTI)	2 Participants

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.

Time frame: Baseline (Pre-dose on Day 1) and up to Week 48 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 Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 2+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Any Increase	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to 1+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to Trace	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 1+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 3+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 2+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to Trace	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 3+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 4+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 4+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Any Increase	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to 1+	4 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Any Increase	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to Trace	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 2+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 3+	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Any Increase	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to Trace	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 1+	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 2+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 3+	0 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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 1 have been presented.

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 the specified time points were analyzed.

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%	50 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%	30 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%	0 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%	0 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%	40 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%	0 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%	0 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%	0 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%	0 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%	20 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%	20 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%	0 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%	0 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%	50 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%	0 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%	0 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%	0 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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	80 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	36 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	73 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	75 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	80 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	64 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	88 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	73 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	50 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	67 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	36 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	64 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	83 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	91 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	88 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	27 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	80 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	38 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	63 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	38 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	100 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	20 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	13 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	40 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	80 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	88 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	18 Percentage of participants

Secondary

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

TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.

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 the specified time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 24	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 12	30 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 36	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 6	20 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 2	10 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 36	100 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 48	100 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 2	55 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 6	91 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 12	73 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)	Week 24	100 Percentage of participants

Secondary

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

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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 24	40.43 Percent change	Standard Deviation 55.177
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 6	10.88 Percent change	Standard Deviation 53.306
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 12	12.56 Percent change	Standard Deviation 49.011
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 2	4.14 Percent change	Standard Deviation 28.531
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 18	39.79 Percent change	Standard Deviation 36.933
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 30	125.17 Percent change	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 36	61.77 Percent change	Standard Deviation 46.781
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 42	64.19 Percent change	Standard Deviation 34.387
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 6	76.99 Percent change	Standard Deviation 58.964
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 48	50.60 Percent change	Standard Deviation 24.805
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 2	45.29 Percent change	Standard Deviation 38.91
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 12	53.75 Percent change	Standard Deviation 53.789
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 18	71.03 Percent change	Standard Deviation 66.792
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 24	68.36 Percent change	Standard Deviation 54.836
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 30	58.16 Percent change	Standard Deviation 51.203

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-35.00 Percent change	Standard Deviation 21.213
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-10.58 Percent change	Standard Deviation 61.416
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 30	-38.46 Percent change	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-4.77 Percent change	Standard Deviation 60.523
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-24.07 Percent change	Standard Deviation 38.593
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-42.31 Percent change	Standard Deviation 10.879
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-59.07 Percent change	Standard Deviation 35.043
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-74.71 Percent change	Standard Deviation 36.316
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-67.64 Percent change	Standard Deviation 38.644
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 48	-80.67 Percent change	Standard Deviation 26.39
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-91.07 Percent change	Standard Deviation 11.453
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 30	-79.99 Percent change	Standard Deviation 20.033
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 36	-78.83 Percent change	Standard Deviation 34.519
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 42	-78.70 Percent change	Standard Deviation 37.029
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-79.82 Percent change	Standard Deviation 24.361

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. 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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 6	1.10 Percent change	Standard Deviation 16.719
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 30	-27.27 Percent change	—
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 2	-0.40 Percent change	Standard Deviation 14.219
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 12	6.71 Percent change	Standard Deviation 20.18
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 18	-7.01 Percent change	Standard Deviation 15.803
Treatment Cycle 1: Placebo	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 24	-18.94 Percent change	Standard Deviation 3.214
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 36	-20.61 Percent change	Standard Deviation 29.216
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 42	-14.15 Percent change	Standard Deviation 26.549
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 12	-19.59 Percent change	Standard Deviation 29.442
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 48	-16.20 Percent change	Standard Deviation 27.755
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 2	-5.62 Percent change	Standard Deviation 20.907
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 6	-19.57 Percent change	Standard Deviation 26.762
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 18	-26.61 Percent change	Standard Deviation 27.085
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 24	-24.02 Percent change	Standard Deviation 26.58
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids	Week 30	-19.61 Percent change	Standard Deviation 28.811

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment

Participants can be 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 at least 4 episodes of urinary incontinence, with no more than one incontinence-free day, post-void residual (PVR) urine volume must have been \<200 mL for participants who micturated or had a mixed catheterization / spontaneous micturition pattern, body weight \>=40 kilogram; 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 gave Yes response to the question of participants qualification for 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 Qualification for Retreatment After First Treatment	85.0 Days
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment	246.0 Days

Secondary

Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment

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 provided Yes response to the question of participants request for 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 After First Treatment	84.5 Days
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment	246.0 Days

Secondary

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

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

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 30	65.55 Milliliter	Standard Deviation 196.119
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 36	-42.23 Milliliter	Standard Deviation 114.691
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 0	7.83 Milliliter	Standard Deviation 84.215
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 2	37.32 Milliliter	Standard Deviation 78.467
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 6	54.67 Milliliter	Standard Deviation 68.852
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 12	51.28 Milliliter	Standard Deviation 76.675
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 18	-10.38 Milliliter	Standard Deviation 60.659
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 24	78.17 Milliliter	Standard Deviation 96.434
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 12	77.25 Milliliter	Standard Deviation 68.182
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 0	21.59 Milliliter	Standard Deviation 38.13
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 24	57.00 Milliliter	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 18	60.33 Milliliter	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 6	66.35 Milliliter	Standard Deviation 76.721
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition	Week 2	76.01 Milliliter	Standard Deviation 71.37

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 0	0.16 Degree Celsius	Standard Deviation 0.44
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 2	0.05 Degree Celsius	Standard Deviation 0.536
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 6	0.15 Degree Celsius	Standard Deviation 0.387
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 12	-0.02 Degree Celsius	Standard Deviation 0.315
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 24	0.53 Degree Celsius	Standard Deviation 0.629
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 48	0.26 Degree Celsius	Standard Deviation 0.559
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 24	0.10 Degree Celsius	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 0	-0.23 Degree Celsius	Standard Deviation 0.186
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 12	0.02 Degree Celsius	Standard Deviation 0.264
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 2	-0.07 Degree Celsius	Standard Deviation 0.388
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 48	-0.10 Degree Celsius	Standard Deviation 0.173
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature	Week 6	0.03 Degree Celsius	Standard Deviation 0.344

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 0	3.7 Beats per minute	Standard Deviation 12.57
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 2	0.1 Beats per minute	Standard Deviation 15.21
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 6	0.7 Beats per minute	Standard Deviation 16.75
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 12	-2.9 Beats per minute	Standard Deviation 16.59
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 24	-5.3 Beats per minute	Standard Deviation 14.86
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 48	-8.6 Beats per minute	Standard Deviation 7.83
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 24	26.0 Beats per minute	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 0	-3.5 Beats per minute	Standard Deviation 13.47
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 12	-1.8 Beats per minute	Standard Deviation 14.86
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 2	0.5 Beats per minute	Standard Deviation 13.87
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 48	1.3 Beats per minute	Standard Deviation 1.53
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate	Week 6	2.2 Beats per minute	Standard Deviation 11.97

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score

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 or E (1\[Never\] to 4\[All the time\]) and S or 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 or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or 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 (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, Week 12, Week 24, and Week 36 in Treatment Cycle 2

Population: FAS2 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 12	-9.88 Scores on a scale	Standard Deviation 35.765
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 12	-25.93 Scores on a scale	Standard Deviation 27.778
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 24	-33.33 Scores on a scale	Standard Deviation 40.825
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 36	-33.33 Scores on a scale	Standard Deviation 33.333
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 0	-13.33 Scores on a scale	Standard Deviation 29.187
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 6	-36.67 Scores on a scale	Standard Deviation 36.683
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 12	-37.04 Scores on a scale	Standard Deviation 40.635
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 24	-43.33 Scores on a scale	Standard Deviation 34.561
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 36	-27.78 Scores on a scale	Standard Deviation 25.459
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 6	-38.33 Scores on a scale	Standard Deviation 29.45
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 12	-40.74 Scores on a scale	Standard Deviation 36.43
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 24	-26.67 Scores on a scale	Standard Deviation 30.277
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 36	-38.89 Scores on a scale	Standard Deviation 25.459
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 0	-21.11 Scores on a scale	Standard Deviation 19.209
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 6	-35.56 Scores on a scale	Standard Deviation 35.058
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 12	-44.44 Scores on a scale	Standard Deviation 24.845
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 24	-44.44 Scores on a scale	Standard Deviation 28.328
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 36	-37.04 Scores on a scale	Standard Deviation 46.259
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 0	4.17 Scores on a scale	Standard Deviation 45.207
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 6	-20.83 Scores on a scale	Standard Deviation 50.198
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 12	-14.29 Scores on a scale	Standard Deviation 45.571
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 24	-16.67 Scores on a scale	Standard Deviation 59.317
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 36	-22.22 Scores on a scale	Standard Deviation 38.49
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 0	-3.33 Scores on a scale	Standard Deviation 22.253
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 6	-16.67 Scores on a scale	Standard Deviation 35.234
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health perception, Week 0	2.5 Scores on a scale	Standard Deviation 18.45
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 24	-24.44 Scores on a scale	Standard Deviation 39.597
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 36	-3.70 Scores on a scale	Standard Deviation 39.021
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 0	-10.00 Scores on a scale	Standard Deviation 21.082
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 6	-23.33 Scores on a scale	Standard Deviation 21.082
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 12	-16.67 Scores on a scale	Standard Deviation 16.667
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 24	-20.00 Scores on a scale	Standard Deviation 27.386
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 36	0.00 Scores on a scale	Standard Deviation 16.667
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 0	-15.33 Scores on a scale	Standard Deviation 13.717
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 6	-25.33 Scores on a scale	Standard Deviation 23.476
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 12	-25.93 Scores on a scale	Standard Deviation 25.483
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 36	-24.44 Scores on a scale	Standard Deviation 20.367
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 0	-21.67 Scores on a scale	Standard Deviation 28.382
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 24	-32.00 Scores on a scale	Standard Deviation 21.807
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health perception, Week 6	5.0 Scores on a scale	Standard Deviation 15.81
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 12	5.6 Scores on a scale	Standard Deviation 20.83
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 24	10.0 Scores on a scale	Standard Deviation 13.69
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 36	8.3 Scores on a scale	Standard Deviation 14.43
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 0	-6.67 Scores on a scale	Standard Deviation 34.427
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 6	-26.67 Scores on a scale	Standard Deviation 40.976
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health perception, Week 6	4.2 Scores on a scale	Standard Deviation 18.82
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 0	-16.67 Scores on a scale	Standard Deviation 34.96
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 6	-5.56 Scores on a scale	Standard Deviation 37.515
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 12	-5.56 Scores on a scale	Standard Deviation 51.28
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 0	3.70 Scores on a scale	Standard Deviation 58.654
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 6	-2.78 Scores on a scale	Standard Deviation 57.922
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 24	33.33 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 24	-33.33 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 0	-0.00 Scores on a scale	Standard Deviation 36.515
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health perception, Week 0	12.5 Scores on a scale	Standard Deviation 20.92
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 24	16.67 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 24	-33.33 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 12	12.5 Scores on a scale	Standard Deviation 34.46
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 0	-3.70 Scores on a scale	Standard Deviation 25.01
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 24	-25.0 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 6	-5.56 Scores on a scale	Standard Deviation 29.187
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 6	-5.56 Scores on a scale	Standard Deviation 38.968
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 12	-8.33 Scores on a scale	Standard Deviation 57.494
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 6	-33.33 Scores on a scale	Standard Deviation 47.14
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 0	-12.22 Scores on a scale	Standard Deviation 19.513
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 12	-33.33 Scores on a scale	Standard Deviation 47.14
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 12	-7.41 Scores on a scale	Standard Deviation 38.915
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 24	-33.33 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 12	-16.67 Scores on a scale	Standard Deviation 34.96
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 0	5.56 Scores on a scale	Standard Deviation 25.459
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 0	2.78 Scores on a scale	Standard Deviation 35.616
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Emotions; Week 24	-33.33 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 6	27.78 Scores on a scale	Standard Deviation 63.099
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 12	0.00 Scores on a scale	Standard Deviation 38.006
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 12	-11.11 Scores on a scale	Standard Deviation 22.965
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 24	0.00 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 12	22.22 Scores on a scale	Standard Deviation 67.358
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 0	2.78 Scores on a scale	Standard Deviation 41.388
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 6	-11.11 Scores on a scale	Standard Deviation 22.178
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 6	0.00 Scores on a scale	Standard Deviation 55.777
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 24	66.67 Scores on a scale	—

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U

PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2

Population: Safety Population 2. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 2	-129.8 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 6	-129.8 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 12	-144.8 Milliliter

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2

Population: Safety Population 1. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (MEDIAN)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Week 2	46.5 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Week 6	42 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Week 12	1 Milliliter

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 0	3.3 Millimeters of mercury	Standard Deviation 9.57
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 2	-2.3 Millimeters of mercury	Standard Deviation 16.64
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 12	-1.2 Millimeters of mercury	Standard Deviation 12.71
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 24	4.5 Millimeters of mercury	Standard Deviation 9.95
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 48	3.8 Millimeters of mercury	Standard Deviation 10.38
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 6	2.6 Millimeters of mercury	Standard Deviation 12.52
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 24	3.5 Millimeters of mercury	Standard Deviation 15.26
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 48	-0.2 Millimeters of mercury	Standard Deviation 13.85
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 0	-0.4 Millimeters of mercury	Standard Deviation 10.7
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 2	-3.5 Millimeters of mercury	Standard Deviation 12.55
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 6	1.0 Millimeters of mercury	Standard Deviation 8.25
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 12	-4.6 Millimeters of mercury	Standard Deviation 7.73
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 12	6.0 Millimeters of mercury	Standard Deviation 2.76
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 0	0.3 Millimeters of mercury	Standard Deviation 8.19
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 0	-1.3 Millimeters of mercury	Standard Deviation 7.26
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 6	12.3 Millimeters of mercury	Standard Deviation 8.09
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 24	-1.0 Millimeters of mercury	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 12	5.2 Millimeters of mercury	Standard Deviation 7.44
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 6	4.2 Millimeters of mercury	Standard Deviation 10.76
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 24	6.0 Millimeters of mercury	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 48	16.0 Millimeters of mercury	Standard Deviation 12.17
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 48	11.3 Millimeters of mercury	Standard Deviation 10.07
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	SBP, Week 2	8.2 Millimeters of mercury	Standard Deviation 8.95
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP	DBP, Week 2	4.3 Millimeters of mercury	Standard Deviation 10.61

Secondary

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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS2 comprised all randomized participants who had at least 1 post-second treatment efficacy assessment after the second treatment.

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-0.33 Episodes	Standard Deviation 2.439
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-3.17 Episodes	Standard Deviation 2.602
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-2.56 Episodes	Standard Deviation 2.939
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-2.67 Episodes	Standard Deviation 2.041
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-2.27 Episodes	Standard Deviation 3.157
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 30	-1.11 Episodes	Standard Deviation 3.657
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 36	0.33 Episodes	Standard Deviation 4.243
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-2.77 Episodes	Standard Deviation 2.735
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-0.89 Episodes	Standard Deviation 1.026
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-1.50 Episodes	Standard Deviation 0.983
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-1.06 Episodes	Standard Deviation 1.124
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-1.33 Episodes	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-1.67 Episodes	Standard Deviation 0.919
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-1.00 Episodes	—

Secondary

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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 0	0.10 Voids	Standard Deviation 2.091
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 6	-1.33 Voids	Standard Deviation 1.305
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 12	-0.96 Voids	Standard Deviation 1.679
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 18	0.80 Voids	Standard Deviation 0.869
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 24	0.67 Voids	Standard Deviation 1.247
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 30	1.33 Voids	Standard Deviation 2
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 36	2.17 Voids	Standard Deviation 1.65
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 2	-0.90 Voids	Standard Deviation 1.343
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 0	-0.22 Voids	Standard Deviation 1.601
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 12	0.06 Voids	Standard Deviation 1.902
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 2	-0.72 Voids	Standard Deviation 1.652
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 24	0.33 Voids	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 6	-1.28 Voids	Standard Deviation 1.819
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids	Week 18	2.67 Voids	—

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U

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 200 U / GSK1358820 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U

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 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U

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 Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U

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 Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings

Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.

Time frame: Week 12 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 the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-NCS	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-CS	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-NCS	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-NCS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-NCS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-CS	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U

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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.

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 200 U / GSK1358820 200 U	SAEs	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U	Non-SAEs	5 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U

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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. Safety population 1 comprised of all participants who received at least one dose of GSK1358820.

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 200 U	SAEs	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U	Non-SAEs	5 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

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. Only categories with non-zero values have been presented.

Time frame: Week 12 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 the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Potassium, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Potassium, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12: Albumin, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Sodium, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Direct Bil, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Sodium, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Total Bil, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Normal or no change	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, High	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, High	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Albumin, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Normal or no change	9 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12: Albumin, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Albumin, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Direct Bil, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Total Bil, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, Normal or no change	4 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, High	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, High	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Potassium, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Potassium, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Sodium, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Sodium, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, Normal or no change	3 Participants

Secondary

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

Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, 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. Only categories with non-zero values have been presented.

Time frame: Week 12 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 the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Hb,Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hb, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Monocytes, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Basophils, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Basophils, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Eosinophils, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: Hb,Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Hct, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hct, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Lympho, Normal or No change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: N bands, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, Normal or no change	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, High	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48:T neutro, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Normal or no change	8 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, Normal or No change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, High	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:RBC count, Normal or no change	9 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, Normal or No Change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Normal to no change	7 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, High	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:WBC count, Normal to no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: Hb,Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Monocytes, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Normal to no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:RBC count, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: N bands, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Basophils, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, Normal or No Change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Basophils, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Eosinophils, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Hb,Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, Normal or No change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hb, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Hct, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:WBC count, Normal to no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hct, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48:T neutro, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Normal or no change	6 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Lympho, Normal or No change	3 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis 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 With UTI: GSK1358820 200 U/GSK1358820 200 U	1 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.

Time frame: Up to Week 48 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 200 U	3 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1) and 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 Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Any Increase	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 3+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to Trace	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to 1+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 1+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Any Increase	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 2+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 2+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 3+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 4+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 4+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to Trace	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 2+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 3+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to Trace	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to 1+	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Any Increase	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to Trace	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 1+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 2+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 3+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Any Increase	2 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 Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 2 have been presented.

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

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 36; >=50%	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 Incontinence Episodes	Week 24 >=75%	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 Incontinence Episodes	Week 0, 100%	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 2, >=75%	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 Incontinence Episodes	Week 2, >=50%	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 Incontinence Episodes	Week 6, 100%	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 6, >=75%	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 Incontinence Episodes	Week 6, >=50%	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 Incontinence Episodes	Week 12, 100%	33 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%	44 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%	67 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%	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 18, >=75%	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 18, >=50%	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 Incontinence Episodes	Week 24, 100%	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 >=50%	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 Incontinence Episodes	Week 30; 100%	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 30; >=75%	33 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%	67 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%	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 36; >=75%	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 0, >=75%	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 0, >=50%	20 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%	20 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	17 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	17 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	50 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	50 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	67 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on 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 the specified time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 36	67 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 12	67 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 0	30 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 2	70 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 6	80 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 24	80 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 6	83 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 12	67 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 0	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 2	67 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS	Week 24	100 Percentage of participants

Secondary

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

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 18	-0.52 Percent change	Standard Deviation 25.276
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 2	25.73 Percent change	Standard Deviation 51.374
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 24	60.12 Percent change	Standard Deviation 78.234
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 0	13.72 Percent change	Standard Deviation 54.613
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 30	68.58 Percent change	Standard Deviation 141.433
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 36	-6.52 Percent change	Standard Deviation 52.333
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 12	30.25 Percent change	Standard Deviation 41.977
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 6	37.32 Percent change	Standard Deviation 36.603
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 12	49.41 Percent change	Standard Deviation 50.11
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 0	13.97 Percent change	Standard Deviation 26.244
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 6	42.20 Percent change	Standard Deviation 50.162
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 2	48.31 Percent change	Standard Deviation 37.054
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 18	42.19 Percent change	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 24	39.86 Percent change	—

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-2.77 Percent change	Standard Deviation 59.552
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-67.47 Percent change	Standard Deviation 43.984
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-43.22 Percent change	Standard Deviation 65.093
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-57.56 Percent change	Standard Deviation 36.509
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-33.05 Percent change	Standard Deviation 113.201
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 30	1.28 Percent change	Standard Deviation 130.221
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 36	52.56 Percent change	Standard Deviation 161.365
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-61.89 Percent change	Standard Deviation 45.317
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-33.80 Percent change	Standard Deviation 37.522
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-53.24 Percent change	Standard Deviation 36.701
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-46.30 Percent change	Standard Deviation 48.39
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 24	-44.44 Percent change	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-60.53 Percent change	Standard Deviation 32.686
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-33.33 Percent change	—

Secondary

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

Time frame: Baseline (Day 1, 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 the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 36	28.33 Percent change	Standard Deviation 18.856
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 0	3.72 Percent change	Standard Deviation 22.732
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 2	-8.40 Percent change	Standard Deviation 13.821
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 6	-13.12 Percent change	Standard Deviation 11.015
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 12	-8.49 Percent change	Standard Deviation 16.813
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 18	10.33 Percent change	Standard Deviation 10.827
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 30	17.53 Percent change	Standard Deviation 25.469
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 24	8.18 Percent change	Standard Deviation 15.795
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 0	-1.67 Percent change	Standard Deviation 18.046
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 12	1.97 Percent change	Standard Deviation 22.031
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 2	-7.31 Percent change	Standard Deviation 18.173
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 24	3.13 Percent change	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 6	-16.44 Percent change	Standard Deviation 25.83
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids	Week 18	25.00 Percent change	—

Secondary

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

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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 2	-17.78 Milliliter	Standard Deviation 114.257
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 12	-0.96 Milliliter	Standard Deviation 77.369
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 6	-1.29 Milliliter	Standard Deviation 116.143
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 18	-0.72 Milliliter	Standard Deviation 3.02
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 0	-3.56 Milliliter	Standard Deviation 78.698
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 18	49.03 Milliliter	Standard Deviation 21.572
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 0	68.62 Milliliter	Standard Deviation 58.163
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 2	71.52 Milliliter	Standard Deviation 51.555
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 6	59.27 Milliliter	Standard Deviation 85.777
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition	Week 12	79.73 Milliliter	Standard Deviation 26.835

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 12	0.15 Degree Celsius	Standard Deviation 0.37
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 0	0.06 Degree Celsius	Standard Deviation 0.114
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 6	0.20 Degree Celsius	Standard Deviation 0.485
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 48	0.08 Degree Celsius	Standard Deviation 0.476
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 2	0.24 Degree Celsius	Standard Deviation 0.27
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 48	0.13 Degree Celsius	Standard Deviation 0.666
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 2	0.23 Degree Celsius	Standard Deviation 0.577
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 6	0.17 Degree Celsius	Standard Deviation 0.351
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 12	0.10 Degree Celsius	Standard Deviation 0.283
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature	Week 0	-0.03 Degree Celsius	Standard Deviation 0.153

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 6	10.8 Beats per minute	Standard Deviation 19.07
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 2	5.4 Beats per minute	Standard Deviation 15.71
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 12	8.5 Beats per minute	Standard Deviation 10.63
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 48	13.8 Beats per minute	Standard Deviation 12.62
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 0	8.4 Beats per minute	Standard Deviation 12.9
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 48	2.7 Beats per minute	Standard Deviation 16.5
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 0	-5.0 Beats per minute	Standard Deviation 8.89
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 2	-3.7 Beats per minute	Standard Deviation 23.71
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 6	-7.0 Beats per minute	Standard Deviation 10.54
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate	Week 12	-4.0 Beats per minute	Standard Deviation 8.49

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 24	-11.11 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 0	-12.50 Scores on a scale	Standard Deviation 45.896
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 0	-30.00 Scores on a scale	Standard Deviation 29.814
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 6	-33.33 Scores on a scale	Standard Deviation 66.667
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 0	-20.00 Scores on a scale	Standard Deviation 29.814
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 12	-16.67 Scores on a scale	Standard Deviation 43.033
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 6	-50.00 Scores on a scale	Standard Deviation 35.355
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 24	33.33 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 0	-8.89 Scores on a scale	Standard Deviation 30.832
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health perception, Week 6	5.0 Scores on a scale	Standard Deviation 20.92
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 12	-33.33 Scores on a scale	Standard Deviation 33.333
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 6	-20.00 Scores on a scale	Standard Deviation 30.832
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 12	-15.56 Scores on a scale	Standard Deviation 26.759
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 12	-20.00 Scores on a scale	Standard Deviation 29.814
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 24	22.22 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 0	-16.67 Scores on a scale	Standard Deviation 16.667
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 24	0.00 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 6	-30.00 Scores on a scale	Standard Deviation 13.944
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 0	-30.00 Scores on a scale	Standard Deviation 21.731
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 24	25.0 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 24	33.33 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 0	-22.67 Scores on a scale	Standard Deviation 12.111
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 6	-22.67 Scores on a scale	Standard Deviation 13.824
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 6	-43.33 Scores on a scale	Standard Deviation 32.489
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 12	-24.00 Scores on a scale	Standard Deviation 12.996
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 12	-20.00 Scores on a scale	Standard Deviation 13.944
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 24	-26.67 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 12	-36.67 Scores on a scale	Standard Deviation 27.386
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 6	-40.00 Scores on a scale	Standard Deviation 27.889
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 24	-16.67 Scores on a scale	—
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 0	-37.78 Scores on a scale	Standard Deviation 23.04
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 12	10.0 Scores on a scale	Standard Deviation 13.69
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 6	-46.67 Scores on a scale	Standard Deviation 24.088
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health perception, Week 0	5.0 Scores on a scale	Standard Deviation 20.92
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 12	-40.00 Scores on a scale	Standard Deviation 21.66
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 24	0.00 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 0	66.67 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 0	-4.44 Scores on a scale	Standard Deviation 26.943
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health perception, Week 0	-16.7 Scores on a scale	Standard Deviation 14.43
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health Perception, Week 12	-8.3 Scores on a scale	Standard Deviation 14.43
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 0	-33.33 Scores on a scale	Standard Deviation 0
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 6	-11.11 Scores on a scale	Standard Deviation 38.49
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Incontinence Impact; Week 12	-22.22 Scores on a scale	Standard Deviation 19.245
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 0	5.56 Scores on a scale	Standard Deviation 9.623
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 6	-5.56 Scores on a scale	Standard Deviation 25.459
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Role Limitations; Week 12	5.56 Scores on a scale	Standard Deviation 41.944
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 0	16.67 Scores on a scale	Standard Deviation 0
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 6	11.11 Scores on a scale	Standard Deviation 9.623
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Physical Limitations; Week 12	16.67 Scores on a scale	Standard Deviation 33.333
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 0	9.26 Scores on a scale	Standard Deviation 25.051
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 6	7.41 Scores on a scale	Standard Deviation 39.021
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Social Limitations; Week 12	18.52 Scores on a scale	Standard Deviation 51.62
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	General Health perception, Week 6	-8.3 Scores on a scale	Standard Deviation 14.43
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 6	66.67 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Personal Relationships; Week 12	100.00 Scores on a scale	—
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 6	7.41 Scores on a scale	Standard Deviation 16.973
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 0	7.41 Scores on a scale	Standard Deviation 39.021
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Emotions; Week 12	7.41 Scores on a scale	Standard Deviation 16.973
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 0	-5.56 Scores on a scale	Standard Deviation 25.459
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 6	-5.56 Scores on a scale	Standard Deviation 25.459
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Sleep/Energy; Week 12	0.00 Scores on a scale	Standard Deviation 16.667
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 6	4.44 Scores on a scale	Standard Deviation 16.777
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score	Severity/Coping Measures; Week 12	0.00 Scores on a scale	Standard Deviation 11.547

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 3. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 2	-129.8 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 6	-134.8 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 12	-12.5 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U	Participant 1: Week 48	-90.8 Milliliter

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3

Population: Safety Population 2. Only those participants with data available at the specified data points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Participant 1: Week 2	47 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Participant 1: Week 6	84 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Participant 1: Week 12	0 Milliliter
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U	Participant 1: Week 48	0 Milliliter

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 12	-4.5 Millimeters of mercury	Standard Deviation 5
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 0	-5.0 Millimeters of mercury	Standard Deviation 5.87
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 2	2.6 Millimeters of mercury	Standard Deviation 13.22
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 6	1.8 Millimeters of mercury	Standard Deviation 9.55
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 12	4.3 Millimeters of mercury	Standard Deviation 11.98
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 48	6.0 Millimeters of mercury	Standard Deviation 3.74
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 0	-1.4 Millimeters of mercury	Standard Deviation 4.22
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 2	-1.0 Millimeters of mercury	Standard Deviation 11.25
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 6	-0.6 Millimeters of mercury	Standard Deviation 8.32
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 48	-2.4 Millimeters of mercury	Standard Deviation 5.86
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 2	2.0 Millimeters of mercury	Standard Deviation 12.49
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 12	3.5 Millimeters of mercury	Standard Deviation 0.71
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 48	5.7 Millimeters of mercury	Standard Deviation 15.5
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 0	14.7 Millimeters of mercury	Standard Deviation 8.5
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 48	4.0 Millimeters of mercury	Standard Deviation 15.52
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 2	8.3 Millimeters of mercury	Standard Deviation 6.66
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 0	1.3 Millimeters of mercury	Standard Deviation 3.21
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 6	5.0 Millimeters of mercury	Standard Deviation 6.08
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	DBP, Week 6	6.3 Millimeters of mercury	Standard Deviation 6.66
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP	SBP, Week 12	2.5 Millimeters of mercury	Standard Deviation 3.54

Secondary

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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS3 comprised all randomized participants who had at least 1 post-third treatment efficacy assessment after the third treatment.

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-3.50 Episodes	Standard Deviation 1.732
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-2.87 Episodes	Standard Deviation 2.219
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-3.87 Episodes	Standard Deviation 1.865
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-1.67 Episodes	Standard Deviation 0.943
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-1.47 Episodes	Standard Deviation 2.168
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-1.50 Episodes	Standard Deviation 0.236
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-1.00 Episodes	Standard Deviation 0.577
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-1.44 Episodes	Standard Deviation 0.509
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-1.11 Episodes	Standard Deviation 0.839
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-1.56 Episodes	Standard Deviation 0.385

Secondary

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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 2	-0.50 Voids	Standard Deviation 1.908
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 12	-1.33 Voids	Standard Deviation 2.789
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 6	-0.47 Voids	Standard Deviation 1.626
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 18	-1.83 Voids	Standard Deviation 3.064
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 0	0.27 Voids	Standard Deviation 1.722
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 18	0.17 Voids	Standard Deviation 0.707
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 0	0.56 Voids	Standard Deviation 1.018
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 2	0.22 Voids	Standard Deviation 0.509
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 6	1.00 Voids	Standard Deviation 1.155
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids	Week 12	0.11 Voids	Standard Deviation 0.509

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U

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 200 U / GSK1358820 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U

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 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U

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 Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U

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 Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U	0 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-NCS	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-NCS	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-CS	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 12: A-NCS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-CS	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings	Week 48: A-NCS	1 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U

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. An SAE is 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, or is a congenital anomaly/birth defect or is medically significant. Safety Population 3 comprised of all participants who received three doses of GSK1358820.

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 200 U / GSK1358820 200 U	SAEs	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U	Non-SAEs	3 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo / GSK1358820 200 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 200 U	SAEs	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo / GSK1358820 200 U	Non-SAEs	4 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Direct Bil, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Albumin, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Albumin, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Total Bil, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Potassium, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Potassium, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Sodium, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Sodium, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Low	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, Normal or no change	5 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Sodium, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:ALT, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Uric acid, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Sodium, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Chloride, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Urea/BUN, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Creatinine, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Albumin, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Albumin, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Alk phosp, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Low	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Creatinine, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:ALT, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Alk phosp, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:T protein, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Glucose, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:AST, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Uric acid, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:AST, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Glucose, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Direct Bil, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Direct Bil, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Total Bil, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Potassium, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Total Bil, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Urea/BUN, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Calcium, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Potassium, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:Calcium, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 48:T protein	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters	Week 12:Chloride, Low	0 Participants

Secondary

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

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

Population: Safety Population 1. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Monocytes, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Eosinophils, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: N bands, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Hct, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Normal to no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: Hb,Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Normal or no change	3 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Basophils, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, Normal or No change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hb, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48:T neutro, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:RBC count, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Basophils, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, Normal or No Change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hct, Normal or no change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: WBC count, Low	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: WBC count, Normal or no change	4 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Lympho, Normal or No change	5 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:WBC count, High	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: Hb,Normal or no change	4 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:WBC count, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hct, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Monocytes, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, Normal or No Change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Basophils, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Basophils, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12: Eosinophils, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Eosinophils, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: Hb,Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: Hb,Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48: Hb, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Hct, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:Lympho, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:Lympho, Normal or No change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:Monocytes, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 12:N bands, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: N bands, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:T neutro, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week 48:T neutro, Normal or no change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:PC, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, Normal or No change	3 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:PC, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12:RBC count, Normal or no change	2 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48:RBC count, High	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week12: WBC count, Normal to no change	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: WBC count, Low	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters	Week48: WBC count, Normal or no change	2 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis 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 With UTI: GSK1358820 200 U/GSK1358820 200 U	2 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 200 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. Number of participants with UTI undergoing urine culture and sensitivity analysis 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 With UTI: Placebo/GSK1358820 200 U	2 Participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

Time frame: Baseline (Day 1, pre-dose of Treatment Cycle 1) and 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 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Any Increase	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to Trace	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to 1+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 2+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 3+	1 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 4+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Any Increase	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to Trace	2 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 1+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 2+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 3+	0 Participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 3+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Any Increase	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to Trace	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to Trace	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Occult blood, Increase to 1+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 1+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 4+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 3+	1 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Increase to 2+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Increase to 2+	0 Participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis	Protein, Any Increase	1 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 Incontinence Episodes

Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, \>=75% and \>=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 3 have been presented.

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

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 18, >=50%	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, >=75%	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 6, >=75%	80 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%	80 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%	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, >=50%	60 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%	20 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%	80 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%	80 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%	40 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%	20 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%	20 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, >=50%	40 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%	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	50 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	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%	0 Percentage of participants

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on 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 the specified time points were analyzed.

Arm	Measure	Group	Value (NUMBER)
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 24	0 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 2	100 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 6	80 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 12	60 Percentage of participants
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 0	40 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 0	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 6	67 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 2	33 Percentage of participants
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS	Week 12	67 Percentage of participants

Secondary

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

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 6	3.41 Percent change	Standard Deviation 53.078
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 12	3.29 Percent change	Standard Deviation 33.79
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 0	1.72 Percent change	Standard Deviation 36.379
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 2	-3.15 Percent change	Standard Deviation 50.796
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 18	-0.27 Percent change	Standard Deviation 1.97
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 18	30.61 Percent change	Standard Deviation 23.706
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 6	27.90 Percent change	Standard Deviation 39.969
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 2	43.15 Percent change	Standard Deviation 37.74
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 12	46.12 Percent change	Standard Deviation 7.004
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition	Week 0	35.49 Percent change	Standard Deviation 21.018

Secondary

Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-73.55 Percent change	Standard Deviation 36.601
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-51.18 Percent change	Standard Deviation 31.93
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-76.76 Percent change	Standard Deviation 33.447
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-21.29 Percent change	Standard Deviation 1.825
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-25.47 Percent change	Standard Deviation 47.584
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 18	-48.96 Percent change	Standard Deviation 25.043
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 0	-28.70 Percent change	Standard Deviation 14.254
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 2	-45.83 Percent change	Standard Deviation 18.162
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 6	-43.29 Percent change	Standard Deviation 49.263
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes	Week 12	-56.48 Percent change	Standard Deviation 38.922

Secondary

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

Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.

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

Population: FAS3 Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 0	7.42 Percent change	Standard Deviation 15.64
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 2	-0.38 Percent change	Standard Deviation 12.695
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 12	-7.14 Percent change	Standard Deviation 16.624
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 18	-6.82 Percent change	Standard Deviation 16.071
Treatment Cycle 1: Placebo	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 6	-2.36 Percent change	Standard Deviation 16.615
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 18	3.28 Percent change	Standard Deviation 11.071
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 2	2.42 Percent change	Standard Deviation 6.042
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 6	12.95 Percent change	Standard Deviation 16.327
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 12	2.19 Percent change	Standard Deviation 8.054
Treatment Cycle 1: GSK1358820 200U	Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids	Week 0	8.79 Percent change	Standard Deviation 16.889

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

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 6

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 Body Temperature

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 Score

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6

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 the Daily Average Number of Urinary Incontinence Episodes

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

Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings

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

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline 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 Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

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 Treatment Benefit Scale (TBS)

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

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids

Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment

Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment

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 Body Temperature

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP

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

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

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters

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

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 200 U

Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis

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

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

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

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes

Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids

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

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate

Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score