A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.

A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Low-Dose ICS Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00603278

Enrollment

622

Registered

2008-01-29

Start date

2007-12-31

Completion date

2008-11-30

Last updated

2016-12-28

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

Conditions

Asthma

Keywords

Adolescents, Adults, Pharmacokinetics, Asthma, GW685698X, Pharmacogenetics

Brief summary

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Detailed description

A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose ICS Therapy

Interventions

DRUGGW685698X

GW685698X

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects eligible for enrolment in the study must meet all of the following criteria: * Type of Subject: Outpatient * Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only. * Gender: Male or Eligible Female * To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: * Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject * Implants of levonorgestrel * Injectable progestogen * Oral contraceptive (either combined estrogen/progestin or progestin only) * Any intrauterine device (IUD) with a documented failure rate of less than 1% per year. * Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days). * Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm). * NB: For German sites, female subjects must use a method of birth control other than the double barrier method. * The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds) * Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7. * Asthma Diagnosis: Asthma as defined by the National Institutes of Health \[National Institutes of Health, 2007\]. * Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value during Visit 1. NHANES III predicted values will be used for subjects aged ≥ 12 years and adjustments to predicted values will be made for African American subjects. \[Hankinson, 1999\]. * Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) or one nebulized albuterol/salbutamol solution at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥12% and ≥200mL, then the subject is not eligible for the study and will not be allowed to re-screen. * Current Anti-Asthma Therapy: Subjects must have been using a inhaled corticosteroid for at least 8 weeks prior to Visit 1 and maintained on a stable dose of inhaled corticosteroids for four weeks prior to Visit 1 at one of the following doses: \[fluticasone propionate MDI CFC/HFA \>220mcg exactuator or ≤250mcg ex valve\]; \[fluticasone propionate DPI ≤200mcg\]; \[beclomethasone dipropionate DPI ≤ 420mcg exactuator or ≤ 500mcg ex-valve\]; \[beclomethasone dipropionate HFA (Qvar) ≤ 160mcg exactuator or ≤ 200mcg ex-valve\]; \[budesonide DPI MDI ≤400mcg\]; \[flunisolide ≤ 1000mcg\]; \[triamcinolone acetonide ≤1000mcg\]; \[mometasone furoate DPI \>200mcg or ≤ 220mcg\]; \[ciclesonide MDI HFA ≤ 160mcg ex-actuator dose / ≤ 200mcg ex-valve dose\]. * Short- Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. The use of spacer devices with metered dose inhaler (MDI) or nebulized albuterol/salbutamol will not be allowed during the study with the exception of their use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits. * Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study. * Compliance: Subjects must be able to comply with completion of the Daily Diary (includes paper medical conditions diary). * French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Inclusion Criteria for Randomization At the end of the run-in period, a subject will be eligible to enter the treatment period of the study if he/she meets the following criteria at Visit 3: 1. Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal. 2. Any combination of the daily asthma symptom scores (day-time plus night-time) of ≥1 or albuterol/salbutamol use on at least 4 of the last 7 consecutive days of the run-in period (immediately preceding Visit 3).

Exclusion criteria

* History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. * Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study. * Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1. * Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, clinically significant coronary artery disease, stroke within 3 months of Visit 1, poorly controlled peptic ulcer, immunologic compromise, tuberculosis (current or untreated), Addison's disease, uncontrolled thyroid disorder, known aortic aneurysm, clinically significant cardiac arrhythmia, uncontrolled hypertension, hematological, hepatic, or renal disease, current malignancy, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse. * Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1. * Investigational Medications: A subject must not have participated in a study or used any investigational drug within 30 days prior to Visit 1. * Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the novel dry powder inhaler or DISKUS/ACCUHALER (i.e., lactose or magnesium stearate). * Milk Protein Allergy: History of severe milk protein allergy. * Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable regimen throughout the study period. * Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and non-compliant with study medication or procedures (e.g. completion of daily diary). Neurological or psychiatric disease or history of drug or alcohol abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements excludes study participation. * Tobacco Use : Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco). * Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. * Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1. * Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients who are receiving potent CYP3A4 inhibitors within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).

Design outcomes

Primary

Measure	Time frame	Description
Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	Baseline and Week 8	Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.

Secondary

Measure	Time frame	Description
Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	From Baseline up to Week 8	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	From Baseline up to Week 8	Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	From Baseline up to Week 8	The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	From the first dose of study medication up to Week 8/Early Withdrawal	The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.
Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	From the first dose of study medication up to Week 8/Early Withdrawal	An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=3%) and SAEs.
Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	From Baseline up to Week 8/Early Withdrawal	A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Hematocrit at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Hemoglobin at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	From Baseline up to Week 8	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.
Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	Baseline and Week 8/Early Withdrawal	Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Urine specific gravity at Baseline and Week 8/Early Withdrawal	Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Urine pH at Baseline and Week 8/Early Withdrawal	Baseline and Week 8/Early Withdrawal	Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline and Week 8	A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	Baseline and Week 8	Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Change From Baseline in Heart Rate at Week 8	Baseline and Week 8	Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Red Blood Cells (RBC) Count at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Countries

Canada, Estonia, Germany, Greece, Mexico, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, United States

Participant flow

Pre-assignment details

Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1406 par. were screened, and 622 par. were randomized, out of which 615 par. received at least one dose of study treatment.

Participants by arm

Arm	Count
Placebo Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.	107
GW685698X 100 µg OD Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.	105
GW685698X 200 µg OD Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.	101
GW685698X 300 µg OD Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.	103
GW685698X 400 µg OD Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.	99
FP 250 µg BID Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.	100
Total	615

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Adverse Event	0	3	1	0	2	1
Overall Study	Lack of Efficacy	35	10	11	8	7	14
Overall Study	Lost to Follow-up	1	0	0	0	1	0
Overall Study	Physician Decision	0	1	0	0	2	1
Overall Study	Protocol Violation	3	0	1	1	0	1
Overall Study	Withdrawal by Subject	2	3	1	2	1	2

Baseline characteristics

Characteristic	GW685698X 100 µg OD	Total	Placebo	FP 250 µg BID	GW685698X 400 µg OD	GW685698X 300 µg OD	GW685698X 200 µg OD
Age, Continuous	38.3 Years STANDARD_DEVIATION 16.76	39.4 Years STANDARD_DEVIATION 16.14	39.1 Years STANDARD_DEVIATION 16.19	39.8 Years STANDARD_DEVIATION 16.7	40.7 Years STANDARD_DEVIATION 15.87	39.9 Years STANDARD_DEVIATION 15.57	38.8 Years STANDARD_DEVIATION 15.97
Gender Female	72 Participants	402 Participants	74 Participants	62 Participants	64 Participants	67 Participants	63 Participants
Gender Male	33 Participants	213 Participants	33 Participants	38 Participants	35 Participants	36 Participants	38 Participants
Race/Ethnicity, Customized African American/African HER	2 Participants	16 Participants	5 Participants	3 Participants	4 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized African American/African Heritage & White	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaska Native & White	12 Participants	79 Participants	14 Participants	13 Participants	13 Participants	14 Participants	13 Participants
Race/Ethnicity, Customized Central/South Asian Heritage (HER)	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER	24 Participants	142 Participants	25 Participants	23 Participants	25 Participants	22 Participants	23 Participants
Race/Ethnicity, Customized Missing	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	64 Participants	371 Participants	62 Participants	61 Participants	56 Participants	63 Participants	65 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	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	17 / 107	29 / 105	18 / 101	22 / 103	20 / 99	32 / 100
serious Total, serious adverse events	0 / 107	0 / 105	0 / 101	1 / 103	1 / 99	0 / 100

Outcome results

Primary

Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.

Time frame: Baseline and Week 8

Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	-0.065 Liters	Standard Error 0.0395
GW685698X 100 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.142 Liters	Standard Error 0.0403
GW685698X 200 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.173 Liters	Standard Error 0.0404
GW685698X 300 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.228 Liters	Standard Error 0.0402
GW685698X 400 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.215 Liters	Standard Error 0.0414
FP 250 µg BID	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.160 Liters	Standard Error 0.0409

p-value: <0.00195% CI: [0.096, 0.318]ANCOVA

p-value: <0.00195% CI: [0.127, 0.349]ANCOVA

p-value: <0.00195% CI: [0.182, 0.404]ANCOVA

p-value: <0.00195% CI: [0.167, 0.392]ANCOVA

p-value: <0.00195% CI: [0.114, 0.337]ANCOVA

Secondary

24-hour Urinary Cortisol Excretion at Baseline and Week 8

A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.

Time frame: Baseline and Week 8

Population: Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.

Arm	Measure	Group	Value (MEDIAN)
Placebo	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	68.45 Nanomole per 24 hours (nmol/24hr)
Placebo	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	64.70 Nanomole per 24 hours (nmol/24hr)
GW685698X 100 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	56.80 Nanomole per 24 hours (nmol/24hr)
GW685698X 100 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	60.80 Nanomole per 24 hours (nmol/24hr)
GW685698X 200 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	65.90 Nanomole per 24 hours (nmol/24hr)
GW685698X 200 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	53.00 Nanomole per 24 hours (nmol/24hr)
GW685698X 300 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	64.50 Nanomole per 24 hours (nmol/24hr)
GW685698X 300 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	56.00 Nanomole per 24 hours (nmol/24hr)
GW685698X 400 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	73.40 Nanomole per 24 hours (nmol/24hr)
GW685698X 400 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	62.00 Nanomole per 24 hours (nmol/24hr)
FP 250 µg BID	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	75.69 Nanomole per 24 hours (nmol/24hr)
FP 250 µg BID	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	58.39 Nanomole per 24 hours (nmol/24hr)

Secondary

Change From Baseline in Heart Rate at Week 8

Change from Baseline was calculated as the Week 8 value minus the Baseline value.

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Heart Rate at Week 8	0.8 Beats per minute	Standard Deviation 10.12
GW685698X 100 µg OD	Change From Baseline in Heart Rate at Week 8	0.5 Beats per minute	Standard Deviation 7.65
GW685698X 200 µg OD	Change From Baseline in Heart Rate at Week 8	-0.4 Beats per minute	Standard Deviation 8.9
GW685698X 300 µg OD	Change From Baseline in Heart Rate at Week 8	1.5 Beats per minute	Standard Deviation 10.92
GW685698X 400 µg OD	Change From Baseline in Heart Rate at Week 8	0.5 Beats per minute	Standard Deviation 8.55
FP 250 µg BID	Change From Baseline in Heart Rate at Week 8	-1.7 Beats per minute	Standard Deviation 9.68

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8

Change from Baseline was calculated as the Week 8 value minus the Baseline value.

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	0.8 Millimeters of mercury (mmHg)	Standard Deviation 9.83
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	2.1 Millimeters of mercury (mmHg)	Standard Deviation 6.96
GW685698X 100 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	0.3 Millimeters of mercury (mmHg)	Standard Deviation 12.93
GW685698X 100 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	0.6 Millimeters of mercury (mmHg)	Standard Deviation 9.19
GW685698X 200 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	-0.2 Millimeters of mercury (mmHg)	Standard Deviation 12.06
GW685698X 200 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	-0.3 Millimeters of mercury (mmHg)	Standard Deviation 9.18
GW685698X 300 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	0.9 Millimeters of mercury (mmHg)	Standard Deviation 11.51
GW685698X 300 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	0.0 Millimeters of mercury (mmHg)	Standard Deviation 9.37
GW685698X 400 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	0.9 Millimeters of mercury (mmHg)	Standard Deviation 10.55
GW685698X 400 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	-0.2 Millimeters of mercury (mmHg)	Standard Deviation 8.05
FP 250 µg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	1.1 Millimeters of mercury (mmHg)	Standard Deviation 11.49
FP 250 µg BID	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	1.0 Millimeters of mercury (mmHg)	Standard Deviation 7.9

Secondary

Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8

Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=106, 104, 101, 102, 98, 99	74.1 Grams per liter (G/L)	Standard Deviation 5.03
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n=65, 85, 85, 89, 83, 81	72.0 Grams per liter (G/L)	Standard Deviation 4.68
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n=65, 85, 85, 89, 83, 81	44.0 Grams per liter (G/L)	Standard Deviation 3.06
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=106, 104, 101, 102, 98, 99	45.2 Grams per liter (G/L)	Standard Deviation 3.43
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n=65, 85, 85, 89, 83, 81	44.7 Grams per liter (G/L)	Standard Deviation 3.08
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=106, 104, 101, 102, 98, 99	45.4 Grams per liter (G/L)	Standard Deviation 3.12
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n=65, 85, 85, 89, 83, 81	72.4 Grams per liter (G/L)	Standard Deviation 4.31
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=106, 104, 101, 102, 98, 99	73.3 Grams per liter (G/L)	Standard Deviation 4.16
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n=65, 85, 85, 89, 83, 81	73.3 Grams per liter (G/L)	Standard Deviation 5.28
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=106, 104, 101, 102, 98, 99	45.4 Grams per liter (G/L)	Standard Deviation 3.16
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n=65, 85, 85, 89, 83, 81	45.1 Grams per liter (G/L)	Standard Deviation 2.81
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=106, 104, 101, 102, 98, 99	73.9 Grams per liter (G/L)	Standard Deviation 4.4
GW685698X 300 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=106, 104, 101, 102, 98, 99	45.4 Grams per liter (G/L)	Standard Deviation 2.71
GW685698X 300 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=106, 104, 101, 102, 98, 99	73.7 Grams per liter (G/L)	Standard Deviation 4.42
GW685698X 300 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n=65, 85, 85, 89, 83, 81	72.5 Grams per liter (G/L)	Standard Deviation 3.92
GW685698X 300 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n=65, 85, 85, 89, 83, 81	44.6 Grams per liter (G/L)	Standard Deviation 2.81
GW685698X 400 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n=65, 85, 85, 89, 83, 81	45.3 Grams per liter (G/L)	Standard Deviation 2.91
GW685698X 400 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=106, 104, 101, 102, 98, 99	45.5 Grams per liter (G/L)	Standard Deviation 2.62
GW685698X 400 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=106, 104, 101, 102, 98, 99	74.0 Grams per liter (G/L)	Standard Deviation 4.37
GW685698X 400 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n=65, 85, 85, 89, 83, 81	73.9 Grams per liter (G/L)	Standard Deviation 4.02
FP 250 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n=65, 85, 85, 89, 83, 81	72.8 Grams per liter (G/L)	Standard Deviation 4.16
FP 250 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=106, 104, 101, 102, 98, 99	44.9 Grams per liter (G/L)	Standard Deviation 2.86
FP 250 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n=65, 85, 85, 89, 83, 81	44.5 Grams per liter (G/L)	Standard Deviation 3.19
FP 250 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=106, 104, 101, 102, 98, 99	73.0 Grams per liter (G/L)	Standard Deviation 4.26

Secondary

Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8

Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, W8, n=65, 85, 85, 89, 83, 81	20.1 International units per liter (IU/L)	Standard Deviation 14.37
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, W8, n=65, 85, 85, 89, 83, 81	157.4 International units per liter (IU/L)	Standard Deviation 37.93
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, W8, n=65, 85, 85, 89, 83, 81	21.8 International units per liter (IU/L)	Standard Deviation 8.77
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, BL, n=106, 103, 100, 102, 97, 99	25.2 International units per liter (IU/L)	Standard Deviation 30.81
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, BL, n=106, 104, 101, 102, 98, 99	33.1 International units per liter (IU/L)	Standard Deviation 54.48
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, BL, n=106, 104, 101, 102, 98, 99	22.3 International units per liter (IU/L)	Standard Deviation 21.25
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, W8, n=65, 85, 85, 89, 83, 81	31.5 International units per liter (IU/L)	Standard Deviation 44.86
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, W8, n=65, 85, 84, 89, 83, 81	88.0 International units per liter (IU/L)	Standard Deviation 57.32
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, BL, n=106, 104, 101, 102, 98, 99	89.3 International units per liter (IU/L)	Standard Deviation 58.42
Placebo	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, BL, n=106, 103, 100, 102, 97, 99	173.2 International units per liter (IU/L)	Standard Deviation 66.73
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, W8, n=65, 85, 84, 89, 83, 81	82.8 International units per liter (IU/L)	Standard Deviation 44.87
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, W8, n=65, 85, 85, 89, 83, 81	21.0 International units per liter (IU/L)	Standard Deviation 14.01
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, BL, n=106, 104, 101, 102, 98, 99	90.5 International units per liter (IU/L)	Standard Deviation 61.69
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, BL, n=106, 103, 100, 102, 97, 99	20.8 International units per liter (IU/L)	Standard Deviation 7.81
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, W8, n=65, 85, 85, 89, 83, 81	158.2 International units per liter (IU/L)	Standard Deviation 29.31
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, W8, n=65, 85, 85, 89, 83, 81	20.5 International units per liter (IU/L)	Standard Deviation 7.5
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, BL, n=106, 103, 100, 102, 97, 99	167.1 International units per liter (IU/L)	Standard Deviation 44.88
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, BL, n=106, 104, 101, 102, 98, 99	26.0 International units per liter (IU/L)	Standard Deviation 20.33
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, BL, n=106, 104, 101, 102, 98, 99	20.0 International units per liter (IU/L)	Standard Deviation 14.75
GW685698X 100 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, W8, n=65, 85, 85, 89, 83, 81	30.1 International units per liter (IU/L)	Standard Deviation 41.05
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, BL, n=106, 103, 100, 102, 97, 99	24.8 International units per liter (IU/L)	Standard Deviation 38.56
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, W8, n=65, 85, 85, 89, 83, 81	21.4 International units per liter (IU/L)	Standard Deviation 8.42
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, BL, n=106, 104, 101, 102, 98, 99	27.6 International units per liter (IU/L)	Standard Deviation 21.53
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, W8, n=65, 85, 84, 89, 83, 81	77.9 International units per liter (IU/L)	Standard Deviation 40.64
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, W8, n=65, 85, 85, 89, 83, 81	29.2 International units per liter (IU/L)	Standard Deviation 31.63
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, BL, n=106, 104, 101, 102, 98, 99	20.5 International units per liter (IU/L)	Standard Deviation 15.44
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, W8, n=65, 85, 85, 89, 83, 81	162.5 International units per liter (IU/L)	Standard Deviation 35.17
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, W8, n=65, 85, 85, 89, 83, 81	20.8 International units per liter (IU/L)	Standard Deviation 11.68
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, BL, n=106, 103, 100, 102, 97, 99	173.8 International units per liter (IU/L)	Standard Deviation 129.22
GW685698X 200 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, BL, n=106, 104, 101, 102, 98, 99	83.7 International units per liter (IU/L)	Standard Deviation 56.68
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, BL, n=106, 104, 101, 102, 98, 99	35.2 International units per liter (IU/L)	Standard Deviation 38.16
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, BL, n=106, 104, 101, 102, 98, 99	88.0 International units per liter (IU/L)	Standard Deviation 74.76
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, W8, n=65, 85, 84, 89, 83, 81	77.9 International units per liter (IU/L)	Standard Deviation 37.21
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, BL, n=106, 104, 101, 102, 98, 99	23.4 International units per liter (IU/L)	Standard Deviation 15.65
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, W8, n=65, 85, 85, 89, 83, 81	23.3 International units per liter (IU/L)	Standard Deviation 16.73
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, BL, n=106, 103, 100, 102, 97, 99	22.7 International units per liter (IU/L)	Standard Deviation 10.1
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, W8, n=65, 85, 85, 89, 83, 81	22.7 International units per liter (IU/L)	Standard Deviation 12.58
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, BL, n=106, 103, 100, 102, 97, 99	169.0 International units per liter (IU/L)	Standard Deviation 54.06
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, W8, n=65, 85, 85, 89, 83, 81	160.6 International units per liter (IU/L)	Standard Deviation 30.45
GW685698X 300 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, W8, n=65, 85, 85, 89, 83, 81	34.8 International units per liter (IU/L)	Standard Deviation 39.4
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, BL, n=106, 103, 100, 102, 97, 99	21.2 International units per liter (IU/L)	Standard Deviation 7.1
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, BL, n=106, 103, 100, 102, 97, 99	168.6 International units per liter (IU/L)	Standard Deviation 50.65
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, W8, n=65, 85, 85, 89, 83, 81	22.1 International units per liter (IU/L)	Standard Deviation 18.46
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, BL, n=106, 104, 101, 102, 98, 99	20.4 International units per liter (IU/L)	Standard Deviation 12.7
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, W8, n=65, 85, 85, 89, 83, 81	28.3 International units per liter (IU/L)	Standard Deviation 23.69
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, W8, n=65, 85, 84, 89, 83, 81	81.9 International units per liter (IU/L)	Standard Deviation 40.05
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, BL, n=106, 104, 101, 102, 98, 99	28.2 International units per liter (IU/L)	Standard Deviation 18.36
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, BL, n=106, 104, 101, 102, 98, 99	83.8 International units per liter (IU/L)	Standard Deviation 40.51
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, W8, n=65, 85, 85, 89, 83, 81	169.2 International units per liter (IU/L)	Standard Deviation 31.91
GW685698X 400 µg OD	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, W8, n=65, 85, 85, 89, 83, 81	21.7 International units per liter (IU/L)	Standard Deviation 8.87
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, W8, n=65, 85, 85, 89, 83, 81	21.4 International units per liter (IU/L)	Standard Deviation 8.51
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, W8, n=65, 85, 85, 89, 83, 81	28.4 International units per liter (IU/L)	Standard Deviation 24.14
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, BL, n=106, 104, 101, 102, 98, 99	89.0 International units per liter (IU/L)	Standard Deviation 57.83
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, BL, n=106, 103, 100, 102, 97, 99	167.1 International units per liter (IU/L)	Standard Deviation 57.95
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	AST, BL, n=106, 103, 100, 102, 97, 99	21.4 International units per liter (IU/L)	Standard Deviation 10.18
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, BL, n=106, 104, 101, 102, 98, 99	20.6 International units per liter (IU/L)	Standard Deviation 15.83
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALT, W8, n=65, 85, 85, 89, 83, 81	20.3 International units per liter (IU/L)	Standard Deviation 14.92
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	GGT, BL, n=106, 104, 101, 102, 98, 99	29.5 International units per liter (IU/L)	Standard Deviation 27.6
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	LD, W8, n=65, 85, 85, 89, 83, 81	162.4 International units per liter (IU/L)	Standard Deviation 35.39
FP 250 µg BID	Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8	ALP, W8, n=65, 85, 84, 89, 83, 81	88.6 International units per liter (IU/L)	Standard Deviation 53.16

Secondary

Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8

Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, W8, n=65, 85, 85, 89, 83, 81	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.42
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, BL, n=106, 103, 100, 102, 97, 98	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.41
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, W8, n=65, 85, 85, 89, 83, 81	5.0 Millimoles per liter (mmol/L)	Standard Deviation 0.73
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, W8, n=65, 85, 85, 89, 83, 81	1.3 Millimoles per liter (mmol/L)	Standard Deviation 0.21
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, BL, n=106, 104, 101, 102, 98, 99	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.2
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, W8, n=65, 85, 85, 89, 83, 81	104.8 Millimoles per liter (mmol/L)	Standard Deviation 2.31
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, BL, n=106, 104, 101, 102, 98, 99	5.3 Millimoles per liter (mmol/L)	Standard Deviation 1.87
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, BL, n=106, 103, 100, 102, 97, 99	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, W8, n=65, 85, 84, 89, 83, 81	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, W8, n=65, 85, 85, 89, 83, 81	139.9 Millimoles per liter (mmol/L)	Standard Deviation 2.11
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, BL, n=106, 104, 101, 102, 98, 99	104.8 Millimoles per liter (mmol/L)	Standard Deviation 3.06
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, W8, n=65, 85, 85, 89, 83, 81	22.4 Millimoles per liter (mmol/L)	Standard Deviation 2.08
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, BL, n=106, 104, 101, 102, 98, 99	140.7 Millimoles per liter (mmol/L)	Standard Deviation 3.38
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, BL, n=106, 104, 101, 102, 98, 99	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.09
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, W8, n=65, 85, 84, 89, 83, 81	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.64
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, W8, n=65, 85, 85, 89, 83, 81	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.06
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, BL, n=106, 103, 100, 102, 97, 99	22.9 Millimoles per liter (mmol/L)	Standard Deviation 2.12
Placebo	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, BL, n=106, 103, 100, 102, 98, 99	5.2 Millimoles per liter (mmol/L)	Standard Deviation 0.94
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, BL, n=106, 103, 100, 102, 97, 99	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, W8, n=65, 85, 84, 89, 83, 81	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.53
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, BL, n=106, 103, 100, 102, 97, 98	4.1 Millimoles per liter (mmol/L)	Standard Deviation 0.45
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, W8, n=65, 85, 84, 89, 83, 81	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, W8, n=65, 85, 85, 89, 83, 81	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.47
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, W8, n=65, 85, 85, 89, 83, 81	140.0 Millimoles per liter (mmol/L)	Standard Deviation 1.95
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, BL, n=106, 103, 100, 102, 97, 99	22.5 Millimoles per liter (mmol/L)	Standard Deviation 2.67
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, W8, n=65, 85, 85, 89, 83, 81	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.19
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, BL, n=106, 104, 101, 102, 98, 99	140.6 Millimoles per liter (mmol/L)	Standard Deviation 1.91
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, W8, n=65, 85, 85, 89, 83, 81	22.5 Millimoles per liter (mmol/L)	Standard Deviation 2.4
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, BL, n=106, 104, 101, 102, 98, 99	105.0 Millimoles per liter (mmol/L)	Standard Deviation 2.61
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, BL, n=106, 103, 100, 102, 98, 99	5.4 Millimoles per liter (mmol/L)	Standard Deviation 1.95
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, W8, n=65, 85, 85, 89, 83, 81	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.66
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, W8, n=65, 85, 85, 89, 83, 81	1.3 Millimoles per liter (mmol/L)	Standard Deviation 0.17
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, BL, n=106, 104, 101, 102, 98, 99	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.21
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, BL, n=106, 104, 101, 102, 98, 99	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.22
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, W8, n=65, 85, 85, 89, 83, 81	104.3 Millimoles per liter (mmol/L)	Standard Deviation 2.05
GW685698X 100 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, BL, n=106, 104, 101, 102, 98, 99	5.1 Millimoles per liter (mmol/L)	Standard Deviation 2.07
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, W8, n=65, 85, 85, 89, 83, 81	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.61
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, BL, n=106, 103, 100, 102, 97, 99	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, W8, n=65, 85, 85, 89, 83, 81	140.3 Millimoles per liter (mmol/L)	Standard Deviation 2.05
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, BL, n=106, 104, 101, 102, 98, 99	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.33
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, W8, n=65, 85, 85, 89, 83, 81	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.18
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, W8, n=65, 85, 84, 89, 83, 81	4.3 Millimoles per liter (mmol/L)	Standard Deviation 0.63
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, W8, n=65, 85, 84, 89, 83, 81	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.11
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, BL, n=106, 104, 101, 102, 98, 99	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.07
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, W8, n=65, 85, 85, 89, 83, 81	5.1 Millimoles per liter (mmol/L)	Standard Deviation 1.04
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, BL, n=106, 103, 100, 102, 98, 99	5.1 Millimoles per liter (mmol/L)	Standard Deviation 0.7
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, BL, n=106, 104, 101, 102, 98, 99	5.1 Millimoles per liter (mmol/L)	Standard Deviation 1.9
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, BL, n=106, 103, 100, 102, 97, 99	22.7 Millimoles per liter (mmol/L)	Standard Deviation 2.4
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, BL, n=106, 104, 101, 102, 98, 99	104.7 Millimoles per liter (mmol/L)	Standard Deviation 3.15
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, BL, n=106, 104, 101, 102, 98, 99	141.0 Millimoles per liter (mmol/L)	Standard Deviation 3.13
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, BL, n=106, 103, 100, 102, 97, 98	4.1 Millimoles per liter (mmol/L)	Standard Deviation 0.44
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, W8, n=65, 85, 85, 89, 83, 81	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.03
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, W8, n=65, 85, 85, 89, 83, 81	104.3 Millimoles per liter (mmol/L)	Standard Deviation 2.36
GW685698X 200 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, W8, n=65, 85, 85, 89, 83, 81	22.8 Millimoles per liter (mmol/L)	Standard Deviation 2.72
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, W8, n=65, 85, 85, 89, 83, 81	140.5 Millimoles per liter (mmol/L)	Standard Deviation 2.15
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, W8, n=65, 85, 85, 89, 83, 81	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.17
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, BL, n=106, 104, 101, 102, 98, 99	104.5 Millimoles per liter (mmol/L)	Standard Deviation 2.34
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, W8, n=65, 85, 85, 89, 83, 81	104.4 Millimoles per liter (mmol/L)	Standard Deviation 2.2
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, BL, n=106, 103, 100, 102, 97, 99	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.1
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, W8, n=65, 85, 84, 89, 83, 81	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.11
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, BL, n=106, 103, 100, 102, 97, 99	22.6 Millimoles per liter (mmol/L)	Standard Deviation 2.58
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, W8, n=65, 85, 85, 89, 83, 81	23.1 Millimoles per liter (mmol/L)	Standard Deviation 2.4
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, BL, n=106, 104, 101, 102, 98, 99	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.13
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, W8, n=65, 85, 85, 89, 83, 81	5.1 Millimoles per liter (mmol/L)	Standard Deviation 1.08
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, BL, n=106, 103, 100, 102, 98, 99	5.2 Millimoles per liter (mmol/L)	Standard Deviation 0.84
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, W8, n=65, 85, 85, 89, 83, 81	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.06
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, BL, n=106, 104, 101, 102, 98, 99	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.19
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, BL, n=106, 103, 100, 102, 97, 98	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.46
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, W8, n=65, 85, 84, 89, 83, 81	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.44
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, BL, n=106, 104, 101, 102, 98, 99	140.3 Millimoles per liter (mmol/L)	Standard Deviation 2.07
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, BL, n=106, 104, 101, 102, 98, 99	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.61
GW685698X 300 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, W8, n=65, 85, 85, 89, 83, 81	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.68
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, W8, n=65, 85, 85, 89, 83, 81	1.3 Millimoles per liter (mmol/L)	Standard Deviation 0.26
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, BL, n=106, 103, 100, 102, 98, 99	5.5 Millimoles per liter (mmol/L)	Standard Deviation 2.18
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, W8, n=65, 85, 85, 89, 83, 81	5.1 Millimoles per liter (mmol/L)	Standard Deviation 1.11
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, BL, n=106, 104, 101, 102, 98, 99	104.8 Millimoles per liter (mmol/L)	Standard Deviation 3
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, BL, n=106, 103, 100, 102, 97, 98	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.38
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, BL, n=106, 104, 101, 102, 98, 99	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.16
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, W8, n=65, 85, 84, 89, 83, 81	4.3 Millimoles per liter (mmol/L)	Standard Deviation 0.66
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, W8, n=65, 85, 85, 89, 83, 81	22.8 Millimoles per liter (mmol/L)	Standard Deviation 2.58
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, BL, n=106, 103, 100, 102, 97, 99	22.6 Millimoles per liter (mmol/L)	Standard Deviation 2.24
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, BL, n=106, 104, 101, 102, 98, 99	140.7 Millimoles per liter (mmol/L)	Standard Deviation 2.85
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, W8, n=65, 85, 84, 89, 83, 81	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, BL, n=106, 103, 100, 102, 97, 99	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.12
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, W8, n=65, 85, 85, 89, 83, 81	140.3 Millimoles per liter (mmol/L)	Standard Deviation 2.23
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, W8, n=65, 85, 85, 89, 83, 81	104.0 Millimoles per liter (mmol/L)	Standard Deviation 2.37
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, W8, n=65, 85, 85, 89, 83, 81	4.8 Millimoles per liter (mmol/L)	Standard Deviation 1.6
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, BL, n=106, 104, 101, 102, 98, 99	5.2 Millimoles per liter (mmol/L)	Standard Deviation 2.2
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, BL, n=106, 104, 101, 102, 98, 99	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.19
GW685698X 400 µg OD	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, W8, n=65, 85, 85, 89, 83, 81	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.46
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, BL, n=106, 104, 101, 102, 98, 99	105.0 Millimoles per liter (mmol/L)	Standard Deviation 2.41
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, W8, n=65, 85, 85, 89, 83, 81	1.3 Millimoles per liter (mmol/L)	Standard Deviation 0.19
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, BL, n=106, 104, 101, 102, 98, 99	140.5 Millimoles per liter (mmol/L)	Standard Deviation 1.76
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, W8, n=65, 85, 85, 89, 83, 81	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.05
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, W8, n=65, 85, 84, 89, 83, 81	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.11
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	PI, BL, n=106, 104, 101, 102, 98, 99	1.1 Millimoles per liter (mmol/L)	Standard Deviation 0.22
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, W8, n=65, 85, 85, 89, 83, 81	5.3 Millimoles per liter (mmol/L)	Standard Deviation 1.85
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, BL, n=106, 103, 100, 102, 97, 98	4.1 Millimoles per liter (mmol/L)	Standard Deviation 0.41
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Cholesterol, BL, n=106, 104, 101, 102, 98, 99	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.12
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, BL, n=106, 104, 101, 102, 98, 99	5.3 Millimoles per liter (mmol/L)	Standard Deviation 1.78
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, W8, n=65, 85, 85, 89, 83, 81	22.9 Millimoles per liter (mmol/L)	Standard Deviation 2.37
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	BUN, W8, n=65, 85, 85, 89, 83, 81	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.64
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Sodium, W8, n=65, 85, 85, 89, 83, 81	140.2 Millimoles per liter (mmol/L)	Standard Deviation 1.8
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Potassium, W8, n=65, 85, 84, 89, 83, 81	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.34
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Chloride, W8, n=65, 85, 85, 89, 83, 81	104.4 Millimoles per liter (mmol/L)	Standard Deviation 2.37
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	CO2/BI, BL, n=106, 103, 100, 102, 97, 99	22.6 Millimoles per liter (mmol/L)	Standard Deviation 2.15
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Glucose, BL, n=106, 103, 100, 102, 98, 99	5.5 Millimoles per liter (mmol/L)	Standard Deviation 1.88
FP 250 µg BID	Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8	Calcium, BL, n=106, 103, 100, 102, 97, 99	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.11

Secondary

Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8

Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, W8, n=65, 65, 85, 89, 83, 81	1.8 Micromoles per liter (µmol/L)	Standard Deviation 0.97
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, BL, n=106, 103, 100, 101, 98, 98	2.1 Micromoles per liter (µmol/L)	Standard Deviation 1.23
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, BL, n=106, 104, 101, 102, 98, 99	10.2 Micromoles per liter (µmol/L)	Standard Deviation 5.39
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, W8, n=65, 85, 85, 89, 83, 81	8.5 Micromoles per liter (µmol/L)	Standard Deviation 4.38
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, BL, n=106, 104, 101, 102, 98, 99	326.7 Micromoles per liter (µmol/L)	Standard Deviation 93.33
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, W8, n=65, 85, 85, 89, 83, 81	308.8 Micromoles per liter (µmol/L)	Standard Deviation 89.18
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, BL, n=106, 104, 101, 102, 98, 99	77.9 Micromoles per liter (µmol/L)	Standard Deviation 14.57
Placebo	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, W8, n=65, 85, 85, 89, 83, 81	74.4 Micromoles per liter (µmol/L)	Standard Deviation 15.58
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, W8, n=65, 85, 85, 89, 83, 81	9.6 Micromoles per liter (µmol/L)	Standard Deviation 6.13
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, W8, n=65, 85, 85, 89, 83, 81	74.6 Micromoles per liter (µmol/L)	Standard Deviation 14.95
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, BL, n=106, 103, 100, 101, 98, 98	2.0 Micromoles per liter (µmol/L)	Standard Deviation 1.3
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, BL, n=106, 104, 101, 102, 98, 99	77.9 Micromoles per liter (µmol/L)	Standard Deviation 18.6
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, W8, n=65, 85, 85, 89, 83, 81	318.3 Micromoles per liter (µmol/L)	Standard Deviation 84.85
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, BL, n=106, 104, 101, 102, 98, 99	10.6 Micromoles per liter (µmol/L)	Standard Deviation 6.11
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, W8, n=65, 65, 85, 89, 83, 81	2.0 Micromoles per liter (µmol/L)	Standard Deviation 1.09
GW685698X 100 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, BL, n=106, 104, 101, 102, 98, 99	323.2 Micromoles per liter (µmol/L)	Standard Deviation 83.6
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, W8, n=65, 65, 85, 89, 83, 81	1.9 Micromoles per liter (µmol/L)	Standard Deviation 0.88
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, BL, n=106, 104, 101, 102, 98, 99	9.4 Micromoles per liter (µmol/L)	Standard Deviation 5.2
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, W8, n=65, 85, 85, 89, 83, 81	9.2 Micromoles per liter (µmol/L)	Standard Deviation 4.93
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, W8, n=65, 85, 85, 89, 83, 81	78.5 Micromoles per liter (µmol/L)	Standard Deviation 16.79
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, BL, n=106, 104, 101, 102, 98, 99	319.4 Micromoles per liter (µmol/L)	Standard Deviation 94.9
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, W8, n=65, 85, 85, 89, 83, 81	319.7 Micromoles per liter (µmol/L)	Standard Deviation 93.76
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, BL, n=106, 104, 101, 102, 98, 99	77.8 Micromoles per liter (µmol/L)	Standard Deviation 16.5
GW685698X 200 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, BL, n=106, 103, 100, 101, 98, 98	1.9 Micromoles per liter (µmol/L)	Standard Deviation 1.09
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, BL, n=106, 103, 100, 101, 98, 98	1.9 Micromoles per liter (µmol/L)	Standard Deviation 1.09
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, W8, n=65, 85, 85, 89, 83, 81	314.4 Micromoles per liter (µmol/L)	Standard Deviation 94.26
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, BL, n=106, 104, 101, 102, 98, 99	326.7 Micromoles per liter (µmol/L)	Standard Deviation 95.36
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, W8, n=65, 65, 85, 89, 83, 81	1.9 Micromoles per liter (µmol/L)	Standard Deviation 0.88
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, BL, n=106, 104, 101, 102, 98, 99	9.3 Micromoles per liter (µmol/L)	Standard Deviation 4.65
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, W8, n=65, 85, 85, 89, 83, 81	8.8 Micromoles per liter (µmol/L)	Standard Deviation 4.14
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, W8, n=65, 85, 85, 89, 83, 81	76.9 Micromoles per liter (µmol/L)	Standard Deviation 15.97
GW685698X 300 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, BL, n=106, 104, 101, 102, 98, 99	75.9 Micromoles per liter (µmol/L)	Standard Deviation 15.04
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, W8, n=65, 85, 85, 89, 83, 81	76.2 Micromoles per liter (µmol/L)	Standard Deviation 15.18
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, BL, n=106, 104, 101, 102, 98, 99	323.9 Micromoles per liter (µmol/L)	Standard Deviation 82.3
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, BL, n=106, 103, 100, 101, 98, 98	2.1 Micromoles per liter (µmol/L)	Standard Deviation 0.97
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, W8, n=65, 85, 85, 89, 83, 81	321.1 Micromoles per liter (µmol/L)	Standard Deviation 83.68
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, BL, n=106, 104, 101, 102, 98, 99	75.9 Micromoles per liter (µmol/L)	Standard Deviation 18.24
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, BL, n=106, 104, 101, 102, 98, 99	9.7 Micromoles per liter (µmol/L)	Standard Deviation 5.48
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, W8, n=65, 65, 85, 89, 83, 81	1.8 Micromoles per liter (µmol/L)	Standard Deviation 0.93
GW685698X 400 µg OD	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, W8, n=65, 85, 85, 89, 83, 81	9.2 Micromoles per liter (µmol/L)	Standard Deviation 4.08
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, W8, n=65, 85, 85, 89, 83, 81	8.4 Micromoles per liter (µmol/L)	Standard Deviation 3.03
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, BL, n=106, 104, 101, 102, 98, 99	77.7 Micromoles per liter (µmol/L)	Standard Deviation 15.77
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	TBIL, BL, n=106, 104, 101, 102, 98, 99	8.9 Micromoles per liter (µmol/L)	Standard Deviation 4.02
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, BL, n=106, 104, 101, 102, 98, 99	312.7 Micromoles per liter (µmol/L)	Standard Deviation 85.72
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Uric acid, W8, n=65, 85, 85, 89, 83, 81	311.4 Micromoles per liter (µmol/L)	Standard Deviation 90.62
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, W8, n=65, 65, 85, 89, 83, 81	1.7 Micromoles per liter (µmol/L)	Standard Deviation 0.75
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	DBIL, BL, n=106, 103, 100, 101, 98, 98	1.8 Micromoles per liter (µmol/L)	Standard Deviation 0.9
FP 250 µg BID	Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8	Creatinine, W8, n=65, 85, 85, 89, 83, 81	77.2 Micromoles per liter (µmol/L)	Standard Deviation 16.59

Secondary

Hematocrit at Baseline and Week 8

Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=102, 104, 96, 99, 93, 95	0.42 Proportion of 1	Standard Deviation 0.041
Placebo	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=62, 84, 82, 83, 81, 81	0.41 Proportion of 1	Standard Deviation 0.037
GW685698X 100 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=102, 104, 96, 99, 93, 95	0.43 Proportion of 1	Standard Deviation 0.034
GW685698X 100 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=62, 84, 82, 83, 81, 81	0.42 Proportion of 1	Standard Deviation 0.039
GW685698X 200 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=102, 104, 96, 99, 93, 95	0.42 Proportion of 1	Standard Deviation 0.043
GW685698X 200 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=62, 84, 82, 83, 81, 81	0.42 Proportion of 1	Standard Deviation 0.043
GW685698X 300 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=102, 104, 96, 99, 93, 95	0.42 Proportion of 1	Standard Deviation 0.035
GW685698X 300 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=62, 84, 82, 83, 81, 81	0.41 Proportion of 1	Standard Deviation 0.038
GW685698X 400 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=102, 104, 96, 99, 93, 95	0.42 Proportion of 1	Standard Deviation 0.039
GW685698X 400 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=62, 84, 82, 83, 81, 81	0.42 Proportion of 1	Standard Deviation 0.046
FP 250 µg BID	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=102, 104, 96, 99, 93, 95	0.42 Proportion of 1	Standard Deviation 0.039
FP 250 µg BID	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=62, 84, 82, 83, 81, 81	0.41 Proportion of 1	Standard Deviation 0.055

Secondary

Hemoglobin at Baseline and Week 8

Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=102, 104, 96, 99, 93, 95	137.64 Grams per liter (G/L)	Standard Deviation 13.911
Placebo	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=62, 84, 82, 83, 81, 81	135.09 Grams per liter (G/L)	Standard Deviation 12.043
GW685698X 100 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=102, 104, 96, 99, 93, 95	139.34 Grams per liter (G/L)	Standard Deviation 11.908
GW685698X 100 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=62, 84, 82, 83, 81, 81	136.42 Grams per liter (G/L)	Standard Deviation 13.342
GW685698X 200 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=102, 104, 96, 99, 93, 95	137.74 Grams per liter (G/L)	Standard Deviation 14.028
GW685698X 200 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=62, 84, 82, 83, 81, 81	137.85 Grams per liter (G/L)	Standard Deviation 13.772
GW685698X 300 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=102, 104, 96, 99, 93, 95	138.08 Grams per liter (G/L)	Standard Deviation 11.707
GW685698X 300 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=62, 84, 82, 83, 81, 81	135.30 Grams per liter (G/L)	Standard Deviation 12.36
GW685698X 400 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=102, 104, 96, 99, 93, 95	138.57 Grams per liter (G/L)	Standard Deviation 13.393
GW685698X 400 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=62, 84, 82, 83, 81, 81	138.17 Grams per liter (G/L)	Standard Deviation 15.05
FP 250 µg BID	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=102, 104, 96, 99, 93, 95	136.93 Grams per liter (G/L)	Standard Deviation 14.139
FP 250 µg BID	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=62, 84, 82, 83, 81, 81	135.79 Grams per liter (G/L)	Standard Deviation 18.663

Secondary

Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.

Time frame: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	-4.7 Liters per minute	Standard Error 3.78
GW685698X 100 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	15.6 Liters per minute	Standard Error 3.85
GW685698X 200 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	16.0 Liters per minute	Standard Error 3.89
GW685698X 300 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	25.5 Liters per minute	Standard Error 3.87
GW685698X 400 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	26.0 Liters per minute	Standard Error 3.95
FP 250 µg BID	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	25.1 Liters per minute	Standard Error 3.94

Secondary

Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.

Time frame: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	-2.8 Liters per minute	Standard Error 3.54
GW685698X 100 µg OD	Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	9.1 Liters per minute	Standard Error 3.6
GW685698X 200 µg OD	Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	14.8 Liters per minute	Standard Error 3.65
GW685698X 300 µg OD	Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	15.1 Liters per minute	Standard Error 3.62
GW685698X 400 µg OD	Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	21.0 Liters per minute	Standard Error 3.7
FP 250 µg BID	Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period	18.2 Liters per minute	Standard Error 3.69

Secondary

Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period

The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.

Time frame: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	15.6 Percentage of rescue-free 24-hr periods	Standard Error 3.02
GW685698X 100 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	25.0 Percentage of rescue-free 24-hr periods	Standard Error 3.07
GW685698X 200 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	23.8 Percentage of rescue-free 24-hr periods	Standard Error 3.12
GW685698X 300 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	25.0 Percentage of rescue-free 24-hr periods	Standard Error 3.1
GW685698X 400 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	24.4 Percentage of rescue-free 24-hr periods	Standard Error 3.15
FP 250 µg BID	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	34.5 Percentage of rescue-free 24-hr periods	Standard Error 3.15

Secondary

Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period

Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.

Time frame: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	17.1 Percentage of symptom-free 24-hr periods	Standard Error 2.91
GW685698X 100 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	21.3 Percentage of symptom-free 24-hr periods	Standard Error 2.96
GW685698X 200 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	19.4 Percentage of symptom-free 24-hr periods	Standard Error 2.99
GW685698X 300 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	24.1 Percentage of symptom-free 24-hr periods	Standard Error 2.97
GW685698X 400 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	28.0 Percentage of symptom-free 24-hr periods	Standard Error 3.02
FP 250 µg BID	Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	30.4 Percentage of symptom-free 24-hr periods	Standard Error 3.02

Secondary

Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period

The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.

Time frame: From the first dose of study medication up to Week 8/Early Withdrawal

Population: ITT Population

Arm	Measure	Value (NUMBER)
Placebo	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	35 Participants
GW685698X 100 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	10 Participants
GW685698X 200 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	11 Participants
GW685698X 300 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	8 Participants
GW685698X 400 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	7 Participants
FP 250 µg BID	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	14 Participants

Secondary

Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=3%) and SAEs.

Time frame: From the first dose of study medication up to Week 8/Early Withdrawal

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	32 Participants
Placebo	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	0 Participants
GW685698X 100 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	43 Participants
GW685698X 100 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	0 Participants
GW685698X 200 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	33 Participants
GW685698X 200 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	0 Participants
GW685698X 300 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	41 Participants
GW685698X 300 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	1 Participants
GW685698X 400 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	35 Participants
GW685698X 400 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	1 Participants
FP 250 µg BID	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	42 Participants
FP 250 µg BID	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	0 Participants

Secondary

Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis

A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.

Time frame: From Baseline up to Week 8/Early Withdrawal

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	0 Participants
Placebo	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	107 Participants
GW685698X 100 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	3 Participants
GW685698X 100 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	102 Participants
GW685698X 200 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	2 Participants
GW685698X 200 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	99 Participants
GW685698X 300 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	4 Participants
GW685698X 300 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	99 Participants
GW685698X 400 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	2 Participants
GW685698X 400 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	97 Participants
FP 250 µg BID	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	4 Participants
FP 250 µg BID	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	96 Participants

Secondary

Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal

Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8/Early Withdrawal

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.

Arm	Measure	Group	Value (NUMBER)
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, BL, n=102, 101, 98, 99, 94, 97	76 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, W8, n=63, 85, 84, 82, 82, 82	61 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, BL, n=102, 101, 98, 99, 94, 97	100 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82	7 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, BL, n=102, 101, 98, 99, 94, 97	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7	9 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97	7 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97	6 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, WD, n=9, 4, 1, 2, 3, 7	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, WD, n=9, 4, 1, 2, 3, 7	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, W8,n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, W8, n=63, 85, 84, 82, 82, 82	3 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, W8, n=63, 85, 84, 82, 82, 82	6 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, WD, n=9, 4, 1, 2, 3, 7	9 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, W8, n=63, 85, 84, 82, 82, 82	4 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, WD, n=9, 4, 1, 2, 3, 7	9 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, W8, n=63, 85, 84, 82, 82, 82	2 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97	2 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97	86 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, WD, n=9, 4, 1, 2, 3, 7	8 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 4+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82	3 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, W8, n=63, 85, 84, 82, 82, 82	54 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, BL, n=102, 101, 98, 99, 94, 97	6 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, BL, n=102, 101, 98, 99, 94, 97	19 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82	52 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, WD, n=9, 4, 1, 2, 3, 7	9 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, W8, n=63, 85, 84, 82, 82, 82	2 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, BL, n=102, 101, 98, 99, 94, 97	5 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, BL, n=102, 101, 98, 99, 94, 95	96 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, BL, n=102, 101, 98, 99, 94, 97	97 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, W8, n=63, 85, 84, 82, 82, 82	56 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, BL, n=102, 101, 98, 99, 94, 97	4 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg,W8, n=63, 85, 84, 82, 82, 82	62 Participants
Placebo	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, BL, n=102, 101, 98, 99, 94, 97	96 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, BL, n=102, 101, 98, 99, 94, 95	91 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, W8, n=63, 85, 84, 82, 82, 82	77 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, W8, n=63, 85, 84, 82, 82, 82	3 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, WD, n=9, 4, 1, 2, 3, 7	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg,W8, n=63, 85, 84, 82, 82, 82	83 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, WD, n=9, 4, 1, 2, 3, 7	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, W8, n=63, 85, 84, 82, 82, 82	5 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, BL, n=102, 101, 98, 99, 94, 97	14 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 4+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, WD, n=9, 4, 1, 2, 3, 7	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97	87 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82	65 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82	5 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, W8,n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, W8, n=63, 85, 84, 82, 82, 82	14 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, BL, n=102, 101, 98, 99, 94, 97	6 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, BL, n=102, 101, 98, 99, 94, 97	78 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, W8, n=63, 85, 84, 82, 82, 82	5 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, WD, n=9, 4, 1, 2, 3, 7	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, W8, n=63, 85, 84, 82, 82, 82	80 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, W8, n=63, 85, 84, 82, 82, 82	64 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, BL, n=102, 101, 98, 99, 94, 97	98 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7	4 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97	3 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 100 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97	5 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82	6 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, BL, n=102, 101, 98, 99, 94, 97	98 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, W8, n=63, 85, 84, 82, 82, 82	81 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, BL, n=102, 101, 98, 99, 94, 97	77 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, BL, n=102, 101, 98, 99, 94, 97	7 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, W8, n=63, 85, 84, 82, 82, 82	68 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, W8, n=63, 85, 84, 82, 82, 82	8 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, W8, n=63, 85, 84, 82, 82, 82	6 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, W8,n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97	7 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97	4 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82	4 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, BL, n=102, 101, 98, 99, 94, 97	3 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82	3 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, BL, n=102, 101, 98, 99, 94, 97	13 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, BL, n=102, 101, 98, 99, 94, 97	96 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82	71 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97	3 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, BL, n=102, 101, 98, 99, 94, 97	3 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97	82 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, BL, n=102, 101, 98, 99, 94, 95	85 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, W8, n=63, 85, 84, 82, 82, 82	77 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg,W8, n=63, 85, 84, 82, 82, 82	83 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 4+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, BL, n=102, 101, 98, 99, 94, 97	6 Participants
GW685698X 200 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, W8, n=63, 85, 84, 82, 82, 82	73 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg,W8, n=63, 85, 84, 82, 82, 82	81 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, WD, n=9, 4, 1, 2, 3, 7	2 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, BL, n=102, 101, 98, 99, 94, 97	96 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82	62 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, W8, n=63, 85, 84, 82, 82, 82	4 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, BL, n=102, 101, 98, 99, 94, 97	13 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, BL, n=102, 101, 98, 99, 94, 95	90 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 4+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97	81 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97	8 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, W8, n=63, 85, 84, 82, 82, 82	4 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, W8, n=63, 85, 84, 82, 82, 82	3 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, WD, n=9, 4, 1, 2, 3, 7	2 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, BL, n=102, 101, 98, 99, 94, 97	98 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, BL, n=102, 101, 98, 99, 94, 97	78 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, BL, n=102, 101, 98, 99, 94, 97	7 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, WD, n=9, 4, 1, 2, 3, 7	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97	7 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97	3 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, W8, n=63, 85, 84, 82, 82, 82	12 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, BL, n=102, 101, 98, 99, 94, 97	3 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, WD, n=9, 4, 1, 2, 3, 7	2 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, W8, n=63, 85, 84, 82, 82, 82	78 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, W8, n=63, 85, 84, 82, 82, 82	5 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82	5 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, W8, n=63, 85, 84, 82, 82, 82	65 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, W8,n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 300 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, W8, n=63, 85, 84, 82, 82, 82	63 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, W8, n=63, 85, 84, 82, 82, 82	17 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, W8,n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, BL, n=102, 101, 98, 99, 94, 97	6 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, BL, n=102, 101, 98, 99, 94, 97	90 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97	5 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97	8 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, BL, n=102, 101, 98, 99, 94, 97	91 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, W8, n=63, 85, 84, 82, 82, 82	73 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82	5 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, W8, n=63, 85, 84, 82, 82, 82	75 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, WD, n=9, 4, 1, 2, 3, 7	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, BL, n=102, 101, 98, 99, 94, 97	70 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, WD, n=9, 4, 1, 2, 3, 7	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, W8, n=63, 85, 84, 82, 82, 82	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, W8, n=63, 85, 84, 82, 82, 82	2 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, WD, n=9, 4, 1, 2, 3, 7	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg,W8, n=63, 85, 84, 82, 82, 82	82 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 4+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, BL, n=102, 101, 98, 99, 94, 97	8 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, BL, n=102, 101, 98, 99, 94, 95	81 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, WD, n=9, 4, 1, 2, 3, 7	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97	74 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97	1 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97	5 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, W8, n=63, 85, 84, 82, 82, 82	3 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, W8, n=63, 85, 84, 82, 82, 82	7 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82	63 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, BL, n=102, 101, 98, 99, 94, 97	4 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
GW685698X 400 µg OD	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, BL, n=102, 101, 98, 99, 94, 97	17 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, W8, n=63, 85, 84, 82, 82, 82	4 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, W8, n=63, 85, 84, 82, 82, 82	69 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, BL, n=102, 101, 98, 99, 94, 97	94 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, BL, n=102, 101, 98, 99, 94, 97	88 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/3 G/DL, BL, n=102, 101, 98, 99, 94, 97	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, WD, n=9, 4, 1, 2, 3, 7	7 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, WD, n=9, 4, 1, 2, 3, 7	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, W8, n=63, 85, 84, 82, 82, 82	4 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace or 1/10 G/DL, BL, n=102, 101,98,99,94,97	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, BL, n=102, 101, 98, 99, 94, 95	91 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 3+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 3+, W8, n=63, 85, 84, 82, 82, 82	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Trace, BL, n=102, 101, 98, 99, 94, 97	2 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, BL, n=102, 101, 98, 99, 94, 97	4 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, W8, n=63, 85, 84, 82, 82, 82	80 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, W8, n=63, 85, 84, 82, 82, 82	72 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 4+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, BL, n=102, 101, 98, 99, 94, 97	11 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, BL, n=102, 101, 98, 99, 94, 97	75 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, Neg, WD, n=9, 4, 1, 2, 3, 7	6 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 1+, BL, n=102, 101, 98, 99, 94, 97	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, WD, n=9, 4, 1, 2, 3, 7	6 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Neg, WD, n=9, 4, 1, 2, 3, 7	7 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, BL, n=102, 101, 98, 99, 94, 97	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, W8, n=63, 85, 84, 82, 82, 82	2 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, WD, n=9, 4, 1, 2, 3, 7	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, W8, n=63, 85, 84, 82, 82, 82	3 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 1+, BL, n=102, 101, 98, 99, 94, 97	2 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 2+, W8,n=63, 85, 84, 82, 82, 82	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Trace, BL, n=102, 101, 98, 99, 94, 97	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, W8, n=63, 85, 84, 82, 82, 82	5 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, 2+, BL, n=102, 101, 98, 99, 94, 97	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UOB, 2+, WD, n=9, 4, 1, 2, 3, 7	1 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 3+ or 1 G/DL, W8, n=63, 85, 84, 82, 82, 82	2 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 2+, W8, n=63, 85, 84, 82, 82, 82	3 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, 1+, BL, n=102, 101, 98, 99, 94, 97	11 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, 1+ or 1/4 G/DL, W8, n=63, 85, 84, 82, 82, 82	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, Trace, BL, n=102, 101, 98, 99, 94, 97	2 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, BL, n=102, 101, 98, 99, 94, 97	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, W8, n=63, 85, 84, 82, 82, 82	7 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, W8, n=63, 85, 84, 82, 82, 82	15 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Trace, WD, n=9, 4, 1, 2, 3, 7	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UP, Neg, W8, n=63, 85, 84, 82, 82, 82	61 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 1+, BL, n=102, 101, 98, 99, 94. 97	3 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg,W8, n=63, 85, 84, 82, 82, 82	80 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Neg, BL, n=102, 101, 98, 99, 94, 97	94 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UWBC, 3+, W8, n=63, 85, 84, 82, 82, 82	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UG, Trace, W8, n=63, 85, 84, 82, 82, 82	0 Participants
FP 250 µg BID	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal	UK, Neg, WD, n=9, 4, 1, 2, 3, 7	7 Participants

Secondary

Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=63, 84, 82, 83, 81, 82	0.31 Percentage	Standard Deviation 0.182
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=63, 84, 82, 83, 81, 82	33.51 Percentage	Standard Deviation 8.261
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=63, 84, 82, 83, 81, 82	4.85 Percentage	Standard Deviation 1.798
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=63, 84, 82, 83, 81, 82	4.78 Percentage	Standard Deviation 4.107
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=100, 103, 97, 99, 94, 95	4.48 Percentage	Standard Deviation 3.262
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=100, 103, 97, 99, 94, 95	34.05 Percentage	Standard Deviation 9.683
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95	56.53 Percentage	Standard Deviation 9.391
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=100, 103, 97, 99, 94, 95	4.66 Percentage	Standard Deviation 1.674
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=100, 103, 97, 99, 94, 95	0.33 Percentage	Standard Deviation 0.159
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=100, 103, 97, 99, 94, 95	33.97 Percentage	Standard Deviation 8.817
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=100, 103, 97, 99, 94, 95	4.52 Percentage	Standard Deviation 2.128
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=63, 84, 82, 83, 81, 82	4.82 Percentage	Standard Deviation 3.006
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=63, 84, 82, 83, 81, 82	32.95 Percentage	Standard Deviation 8.183
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=63, 84, 82, 83, 81, 82	0.32 Percentage	Standard Deviation 0.191
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=100, 103, 97, 99, 94, 95	0.32 Percentage	Standard Deviation 0.179
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=100, 103, 97, 99, 94, 95	4.05 Percentage	Standard Deviation 2.882
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=63, 84, 82, 83, 81, 82	3.72 Percentage	Standard Deviation 2.518
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95	58.17 Percentage	Standard Deviation 9.386
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=100, 103, 97, 99, 94, 95	0.35 Percentage	Standard Deviation 0.188
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=63, 84, 82, 83, 81, 82	31.39 Percentage	Standard Deviation 8.668
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=63, 84, 82, 83, 81, 82	4.92 Percentage	Standard Deviation 2.324
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=63, 84, 82, 83, 81, 82	3.54 Percentage	Standard Deviation 2.556
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=100, 103, 97, 99, 94, 95	34.01 Percentage	Standard Deviation 9.214
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=100, 103, 97, 99, 94, 95	4.85 Percentage	Standard Deviation 1.939
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95	59.75 Percentage	Standard Deviation 9.513
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=100, 103, 97, 99, 94, 95	4.05 Percentage	Standard Deviation 2.981
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=63, 84, 82, 83, 81, 82	0.38 Percentage	Standard Deviation 0.227
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=100, 103, 97, 99, 94, 95	4.58 Percentage	Standard Deviation 1.994
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95	60.72 Percentage	Standard Deviation 9.846
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=63, 84, 82, 83, 81, 82	0.33 Percentage	Standard Deviation 0.165
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=100, 103, 97, 99, 94, 95	4.17 Percentage	Standard Deviation 2.649
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=63, 84, 82, 83, 81, 82	3.53 Percentage	Standard Deviation 2.671
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=100, 103, 97, 99, 94, 95	0.31 Percentage	Standard Deviation 0.155
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=100, 103, 97, 99, 94, 95	33.70 Percentage	Standard Deviation 8.38
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=63, 84, 82, 83, 81, 82	30.97 Percentage	Standard Deviation 8.711
GW685698X 300 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=63, 84, 82, 83, 81, 82	4.42 Percentage	Standard Deviation 1.833
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=100, 103, 97, 99, 94, 95	0.33 Percentage	Standard Deviation 0.169
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=100, 103, 97, 99, 94, 95	31.48 Percentage	Standard Deviation 9.075
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=63, 84, 82, 83, 81, 82	3.35 Percentage	Standard Deviation 3.063
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=63, 84, 82, 83, 81, 82	4.18 Percentage	Standard Deviation 2.176
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=100, 103, 97, 99, 94, 95	4.47 Percentage	Standard Deviation 1.954
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=100, 103, 97, 99, 94, 95	4.20 Percentage	Standard Deviation 3.185
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=63, 84, 82, 83, 81, 82	0.32 Percentage	Standard Deviation 0.203
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95	64.75 Percentage	Standard Deviation 8.896
GW685698X 400 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=63, 84, 82, 83, 81, 82	27.38 Percentage	Standard Deviation 7.585
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=100, 103, 97, 99, 94, 95	57.61 Percentage	Standard Deviation 9.681
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=100, 103, 97, 99, 94, 95	0.34 Percentage	Standard Deviation 0.209
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=63, 84, 82, 83, 81, 82	0.35 Percentage	Standard Deviation 0.19
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=100, 103, 97, 99, 94, 95	4.66 Percentage	Standard Deviation 3.393
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=63, 84, 82, 83, 81, 82	4.21 Percentage	Standard Deviation 3.29
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=100, 103, 97, 99, 94, 95	33.61 Percentage	Standard Deviation 9.032
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=63, 84, 82, 83, 81, 82	33.17 Percentage	Standard Deviation 7.607
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=100, 103, 97, 99, 94, 95	4.55 Percentage	Standard Deviation 2.19
FP 250 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=63, 84, 82, 83, 81, 82	4.59 Percentage	Standard Deviation 2.436

Secondary

Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8

Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=60, 84, 80, 81, 80, 80	275.91 10^9 cells per liter (GI/L)	Standard Deviation 53.705
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=62, 84, 82, 83, 81, 81	8.02 10^9 cells per liter (GI/L)	Standard Deviation 1.991
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=101, 103, 96, 99, 93, 95	8.05 10^9 cells per liter (GI/L)	Standard Deviation 2.31
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=98, 103,93, 98, 89, 94	286.23 10^9 cells per liter (GI/L)	Standard Deviation 57.383
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=60, 84, 80, 81, 80, 80	281.40 10^9 cells per liter (GI/L)	Standard Deviation 66.449
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=62, 84, 82, 83, 81, 81	8.06 10^9 cells per liter (GI/L)	Standard Deviation 1.894
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=98, 103,93, 98, 89, 94	277.29 10^9 cells per liter (GI/L)	Standard Deviation 64.358
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=101, 103, 96, 99, 93, 95	7.90 10^9 cells per liter (GI/L)	Standard Deviation 2.11
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=62, 84, 82, 83, 81, 81	7.79 10^9 cells per liter (GI/L)	Standard Deviation 2.066
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=60, 84, 80, 81, 80, 80	277.73 10^9 cells per liter (GI/L)	Standard Deviation 71.595
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=101, 103, 96, 99, 93, 95	7.69 10^9 cells per liter (GI/L)	Standard Deviation 2.086
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=98, 103,93, 98, 89, 94	290.90 10^9 cells per liter (GI/L)	Standard Deviation 98.801
GW685698X 300 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=98, 103,93, 98, 89, 94	282.86 10^9 cells per liter (GI/L)	Standard Deviation 70.086
GW685698X 300 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=62, 84, 82, 83, 81, 81	8.20 10^9 cells per liter (GI/L)	Standard Deviation 1.936
GW685698X 300 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=60, 84, 80, 81, 80, 80	287.98 10^9 cells per liter (GI/L)	Standard Deviation 67.053
GW685698X 300 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=101, 103, 96, 99, 93, 95	8.11 10^9 cells per liter (GI/L)	Standard Deviation 2.332
GW685698X 400 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=60, 84, 80, 81, 80, 80	297.83 10^9 cells per liter (GI/L)	Standard Deviation 76.271
GW685698X 400 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=62, 84, 82, 83, 81, 81	9.07 10^9 cells per liter (GI/L)	Standard Deviation 2.054
GW685698X 400 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=101, 103, 96, 99, 93, 95	8.23 10^9 cells per liter (GI/L)	Standard Deviation 2.027
GW685698X 400 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=98, 103,93, 98, 89, 94	283.01 10^9 cells per liter (GI/L)	Standard Deviation 58.915
FP 250 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=62, 84, 82, 83, 81, 81	8.30 10^9 cells per liter (GI/L)	Standard Deviation 3.119
FP 250 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=98, 103,93, 98, 89, 94	285.45 10^9 cells per liter (GI/L)	Standard Deviation 69.22
FP 250 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=60, 84, 80, 81, 80, 80	287.60 10^9 cells per liter (GI/L)	Standard Deviation 87.009
FP 250 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=101, 103, 96, 99, 93, 95	8.12 10^9 cells per liter (GI/L)	Standard Deviation 2.141

Secondary

Red Blood Cells (RBC) Count at Baseline and Week 8

Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Red Blood Cells (RBC) Count at Baseline and Week 8	BL, n=102, 104, 96, 99, 93, 95	4.66 10^12 cells per liter (TI/L)	Standard Deviation 0.439
Placebo	Red Blood Cells (RBC) Count at Baseline and Week 8	W8, n=62, 84, 82, 83, 81, 80	4.54 10^12 cells per liter (TI/L)	Standard Deviation 0.483
GW685698X 100 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	W8, n=62, 84, 82, 83, 81, 80	4.57 10^12 cells per liter (TI/L)	Standard Deviation 0.447
GW685698X 100 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	BL, n=102, 104, 96, 99, 93, 95	4.68 10^12 cells per liter (TI/L)	Standard Deviation 0.385
GW685698X 200 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	W8, n=62, 84, 82, 83, 81, 80	4.62 10^12 cells per liter (TI/L)	Standard Deviation 0.513
GW685698X 200 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	BL, n=102, 104, 96, 99, 93, 95	4.69 10^12 cells per liter (TI/L)	Standard Deviation 0.539
GW685698X 300 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	BL, n=102, 104, 96, 99, 93, 95	4.63 10^12 cells per liter (TI/L)	Standard Deviation 0.442
GW685698X 300 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	W8, n=62, 84, 82, 83, 81, 80	4.50 10^12 cells per liter (TI/L)	Standard Deviation 0.458
GW685698X 400 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	BL, n=102, 104, 96, 99, 93, 95	4.64 10^12 cells per liter (TI/L)	Standard Deviation 0.395
GW685698X 400 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	W8, n=62, 84, 82, 83, 81, 80	4.66 10^12 cells per liter (TI/L)	Standard Deviation 0.526
FP 250 µg BID	Red Blood Cells (RBC) Count at Baseline and Week 8	W8, n=62, 84, 82, 83, 81, 80	4.52 10^12 cells per liter (TI/L)	Standard Deviation 0.426
FP 250 µg BID	Red Blood Cells (RBC) Count at Baseline and Week 8	BL, n=102, 104, 96, 99, 93, 95	4.61 10^12 cells per liter (TI/L)	Standard Deviation 0.412

Secondary

Urine pH at Baseline and Week 8/Early Withdrawal

Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Time frame: Baseline and Week 8/Early Withdrawal

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Urine pH at Baseline and Week 8/Early Withdrawal	W8, n=62, 84, 82, 83, 82, 82	6.00 scores on a scale	Standard Deviation 0.458
Placebo	Urine pH at Baseline and Week 8/Early Withdrawal	BL, n=102, 104, 96, 99, 94, 97	6.11 scores on a scale	Standard Deviation 0.507
Placebo	Urine pH at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	6.11 scores on a scale	Standard Deviation 0.601
GW685698X 100 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	W8, n=62, 84, 82, 83, 82, 82	6.13 scores on a scale	Standard Deviation 0.518
GW685698X 100 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	BL, n=102, 104, 96, 99, 94, 97	5.98 scores on a scale	Standard Deviation 0.367
GW685698X 100 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	6.13 scores on a scale	Standard Deviation 0.25
GW685698X 200 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	W8, n=62, 84, 82, 83, 82, 82	6.10 scores on a scale	Standard Deviation 0.451
GW685698X 200 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	BL, n=102, 104, 96, 99, 94, 97	6.05 scores on a scale	Standard Deviation 0.455
GW685698X 200 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	6.00 scores on a scale	Standard Deviation 0
GW685698X 300 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	W8, n=62, 84, 82, 83, 82, 82	5.99 scores on a scale	Standard Deviation 0.397
GW685698X 300 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	BL, n=102, 104, 96, 99, 94, 97	5.97 scores on a scale	Standard Deviation 0.383
GW685698X 300 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	6.00 scores on a scale	Standard Deviation 0
GW685698X 400 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	W8, n=62, 84, 82, 83, 82, 82	6.00 scores on a scale	Standard Deviation 0.437
GW685698X 400 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	BL, n=102, 104, 96, 99, 94, 97	6.01 scores on a scale	Standard Deviation 0.37
GW685698X 400 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	5.67 scores on a scale	Standard Deviation 0.289
FP 250 µg BID	Urine pH at Baseline and Week 8/Early Withdrawal	BL, n=102, 104, 96, 99, 94, 97	6.04 scores on a scale	Standard Deviation 0.393
FP 250 µg BID	Urine pH at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	5.93 scores on a scale	Standard Deviation 0.345
FP 250 µg BID	Urine pH at Baseline and Week 8/Early Withdrawal	W8, n=62, 84, 82, 83, 82, 82	6.01 scores on a scale	Standard Deviation 0.368

Secondary

Urine Specific Gravity at Baseline and Week 8/Early Withdrawal

Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.

Time frame: Urine specific gravity at Baseline and Week 8/Early Withdrawal

Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	W8, n=63, 85, 84, 82, 82, 82	1.0225 ratio	Standard Deviation 0.00778
Placebo	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	BL, n=102, 101, 98, 99, 94, 97	1.0232 ratio	Standard Deviation 0.00741
Placebo	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	1.0206 ratio	Standard Deviation 0.00532
GW685698X 100 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	W8, n=63, 85, 84, 82, 82, 82	1.0227 ratio	Standard Deviation 0.00714
GW685698X 100 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	BL, n=102, 101, 98, 99, 94, 97	1.0227 ratio	Standard Deviation 0.00687
GW685698X 100 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	1.0228 ratio	Standard Deviation 0.00772
GW685698X 200 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	W8, n=63, 85, 84, 82, 82, 82	1.0227 ratio	Standard Deviation 0.00655
GW685698X 200 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	BL, n=102, 101, 98, 99, 94, 97	1.0226 ratio	Standard Deviation 0.00718
GW685698X 200 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	1.0380 ratio	Standard Deviation 0
GW685698X 300 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	W8, n=63, 85, 84, 82, 82, 82	1.0223 ratio	Standard Deviation 0.00766
GW685698X 300 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	BL, n=102, 101, 98, 99, 94, 97	1.0224 ratio	Standard Deviation 0.00719
GW685698X 300 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	1.0175 ratio	Standard Deviation 0.01768
GW685698X 400 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	W8, n=63, 85, 84, 82, 82, 82	1.0210 ratio	Standard Deviation 0.00884
GW685698X 400 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	BL, n=102, 101, 98, 99, 94, 97	1.0225 ratio	Standard Deviation 0.00759
GW685698X 400 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	1.0273 ratio	Standard Deviation 0.00306
FP 250 µg BID	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	BL, n=102, 101, 98, 99, 94, 97	1.0245 ratio	Standard Deviation 0.00679
FP 250 µg BID	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	WD, n=9, 4, 1, 2, 3, 7	1.0164 ratio	Standard Deviation 0.00824
FP 250 µg BID	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	W8, n=63, 85, 84, 82, 82, 82	1.0255 ratio	Standard Deviation 0.00726

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8

24-hour Urinary Cortisol Excretion at Baseline and Week 8

Change From Baseline in Heart Rate at Week 8

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8

Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8

Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8

Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8

Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8

Hematocrit at Baseline and Week 8

Hemoglobin at Baseline and Week 8

Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period

Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period

Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period

Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period

Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period

Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period

Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis

Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal

Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8

Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8

Red Blood Cells (RBC) Count at Baseline and Week 8

Urine pH at Baseline and Week 8/Early Withdrawal

Urine Specific Gravity at Baseline and Week 8/Early Withdrawal