A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal 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 Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00603382

Enrollment

599

Registered

2008-01-29

Start date

2007-12-01

Completion date

2008-10-02

Last updated

2018-04-18

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

Conditions

Asthma

Keywords

Adults, Pharmacokinetics, Pharmacogenetics, Asthma, Adolescents, GW685698X

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 Non-Steroidal, Asthma Therapy

Interventions

DRUGGW685698X

GW685698X

DRUGPlacebo

placebo comparator

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 enrollment 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 enrollment 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%-85% of the predicted normal value during the morning Visit 1 screening period or a best FEV1 of 40%-90% of the predicted normal value during the evening Visit 1 screening period. * Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (spacers are permitted for reversibility testing if required) or one nebulized albuterol/salbutamol solution at the screening period. Re-screening of subjects during the Visit 1 screening period: If a subject does not meet the inclusion criteria based upon FEV1 percent predicted and/or reversibility, the subject may return to the site once within 4 days and repeat the lung function tests. * Current Anti-Asthma Therapy: Subjects must have been using a non-corticosteroid controller or short acting beta2-agonist bronchodilators alone (with no inhaled corticosteroids use for at least 6 weeks) for ≥ 3 months preceding Visit 1. * 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: * Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal. * 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 before 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 heart 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 hypertension1, hematological, hepatic, or renal disease, current malignancy2, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse. * systolic blood pressure ≥160, or diastolic blood pressure \>100 * history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1) * Patients with a history of tuberculosis who have received an approved prophylactic treatment regimen or an approved active treatment regimen and who have had no evidence of active disease for a minimum of 2 years may be enrolled \[American Thoracic Society, 2003; American Thoracic Society, 2005\] * 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. Administration of inhaled corticosteroids within 6 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 from the lungs 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 through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. 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 th 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-hour 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.
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 at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Baseline and Week 8	Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. 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 large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 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 (EW). The Baseline value was the measurement taken at screening (Visit 1).
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	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 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr 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

Bulgaria, Canada, Estonia, France, Germany, Mexico, Peru, Philippines, Poland, Russia, Slovakia, South Korea, Sweden, 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. Total 1459 par. were screened, 601 were randomized of which 598 par. received at least one dose of study treatment.

Participants by arm

Arm	Count
Placebo Participants received placebo OD in the evening from the DPI 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.	94
GW685698X 25 µg OD Participants received GW685698X 25 µg OD in the evening from the DPI 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.	97
GW685698X 50 µg OD Participants received GW685698X 50 µg OD in the evening from the DPI 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.	100
GW685698X 100 µg OD Participants received GW685698X 100 µg OD in the evening from the DPI 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.	110
GW685698X 200 µg OD Participants received GW685698X 200 µg OD in the evening from the DPI 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.	95
FP 100 µg BID Participants received FP 100 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 DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.	102
Total	598

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Adverse Event	0	1	1	2	1	2
Overall Study	Lack of Efficacy	14	9	3	6	6	11
Overall Study	Lost to Follow-up	0	1	1	1	0	1
Overall Study	Physician Decision	0	0	2	0	1	3
Overall Study	Protocol Violation	1	0	1	2	1	0
Overall Study	Withdrawal by Subject	3	3	1	1	0	1

Baseline characteristics

Characteristic	Placebo	GW685698X 25 µg OD	GW685698X 50 µg OD	GW685698X 100 µg OD	GW685698X 200 µg OD	FP 100 µg BID	Total
Age, Continuous	39.2 Years STANDARD_DEVIATION 15.82	37.7 Years STANDARD_DEVIATION 15.4	38.3 Years STANDARD_DEVIATION 14.49	36.8 Years STANDARD_DEVIATION 15.56	40.7 Years STANDARD_DEVIATION 15.96	39.9 Years STANDARD_DEVIATION 15.03	38.7 Years STANDARD_DEVIATION 15.37
Race/Ethnicity, Customized AA/AHER & American Indian or Alaska Native	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
Race/Ethnicity, Customized African American/African Heritage (AA/AHER)	5 participants	4 participants	4 participants	8 participants	6 participants	5 participants	32 participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 participants	7 participants	5 participants	6 participants	6 participants	5 participants	34 participants
Race/Ethnicity, Customized American Indian or Alaska Native & White	8 participants	8 participants	9 participants	10 participants	8 participants	8 participants	51 participants
Race/Ethnicity, Customized Asian	7 participants	13 participants	9 participants	10 participants	10 participants	10 participants	59 participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander & White	0 participants	1 participants	1 participants	0 participants	0 participants	0 participants	2 participants
Race/Ethnicity, Customized White	69 participants	64 participants	72 participants	76 participants	64 participants	74 participants	419 participants
Sex: Female, Male Female	47 Participants	57 Participants	59 Participants	60 Participants	60 Participants	56 Participants	339 Participants
Sex: Female, Male Male	47 Participants	40 Participants	41 Participants	50 Participants	35 Participants	46 Participants	259 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	11 / 94	6 / 97	8 / 100	17 / 110	9 / 95	16 / 102
serious Total, serious adverse events	0 / 94	1 / 97	0 / 100	1 / 110	0 / 95	2 / 102

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 from the lungs 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 through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. 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	0.137 Liters	Standard Error 0.0428
GW685698X 25 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.239 Liters	Standard Error 0.0428
GW685698X 50 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.266 Liters	Standard Error 0.042
GW685698X 100 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.341 Liters	Standard Error 0.0396
GW685698X 200 µg OD	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.367 Liters	Standard Error 0.0428
FP 100 µg BID	Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	0.243 Liters	Standard Error 0.0411

p-value: 0.09595% CI: [-0.018, 0.221]ANCOVA

p-value: 0.03395% CI: [0.011, 0.247]ANCOVA

p-value: <0.00195% CI: [0.089, 0.319]ANCOVA

p-value: <0.00195% CI: [0.111, 0.349]ANCOVA

p-value: 0.07495% CI: [-0.01, 0.223]ANCOVA

Secondary

24-hour Urinary Cortisol Excretion at Baseline and Week 8

A 24-hour urine sample was collected for the measurement of 24 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr 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	70.20 Nanomoles per 24 hours (nmol/24 hours)
Placebo	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	79.25 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 25 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	74.45 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 25 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	76.74 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 50 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	65.80 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 50 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	79.15 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 100 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	65.56 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 100 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	81.0 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 200 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	66.80 Nanomoles per 24 hours (nmol/24 hours)
GW685698X 200 µg OD	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	62.10 Nanomoles per 24 hours (nmol/24 hours)
FP 100 µg BID	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Baseline	66.20 Nanomoles per 24 hours (nmol/24 hours)
FP 100 µg BID	24-hour Urinary Cortisol Excretion at Baseline and Week 8	Week 8	82.14 Nanomoles per 24 hours (nmol/24 hours)

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	2.9 Beats per minute	Standard Deviation 9.23
GW685698X 25 µg OD	Change From Baseline in Heart Rate at Week 8	0.4 Beats per minute	Standard Deviation 8.26
GW685698X 50 µg OD	Change From Baseline in Heart Rate at Week 8	1.5 Beats per minute	Standard Deviation 8.35
GW685698X 100 µg OD	Change From Baseline in Heart Rate at Week 8	0.8 Beats per minute	Standard Deviation 8.12
GW685698X 200 µg OD	Change From Baseline in Heart Rate at Week 8	-2.3 Beats per minute	Standard Deviation 8.32
FP 100 µg BID	Change From Baseline in Heart Rate at Week 8	0.8 Beats per minute	Standard Deviation 9.14

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	DBP	-1.1 Millimeters of mercury (mmHg)	Standard Deviation 8.16
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	-2.5 Millimeters of mercury (mmHg)	Standard Deviation 9.29
GW685698X 25 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 7.65
GW685698X 25 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	1.5 Millimeters of mercury (mmHg)	Standard Deviation 10.54
GW685698X 50 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 7.5
GW685698X 50 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 10.35
GW685698X 100 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	-0.4 Millimeters of mercury (mmHg)	Standard Deviation 10.46
GW685698X 100 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 8.41
GW685698X 200 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	DBP	0.1 Millimeters of mercury (mmHg)	Standard Deviation 8.5
GW685698X 200 µg OD	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8	SBP	1.4 Millimeters of mercury (mmHg)	Standard Deviation 9.53
FP 100 µg BID	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 10.64
FP 100 µg BID	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 8.55

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 (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 (MEAN)	Dispersion
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=94, 97, 99, 106, 94, 101	45.2 Grams per liter (g/L)	Standard Deviation 3.18
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n= 78, 84, 90, 97, 86, 83	44.9 Grams per liter (g/L)	Standard Deviation 3.12
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=94, 97, 99, 106, 94, 101	73.2 Grams per liter (g/L)	Standard Deviation 4.04
Placebo	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n= 78, 84, 90, 97, 86, 83	71.9 Grams per liter (g/L)	Standard Deviation 3.65
GW685698X 25 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=94, 97, 99, 106, 94, 101	74.0 Grams per liter (g/L)	Standard Deviation 4.46
GW685698X 25 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n= 78, 84, 90, 97, 86, 83	44.8 Grams per liter (g/L)	Standard Deviation 3.3
GW685698X 25 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=94, 97, 99, 106, 94, 101	45.6 Grams per liter (g/L)	Standard Deviation 3.08
GW685698X 25 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n= 78, 84, 90, 97, 86, 83	72.6 Grams per liter (g/L)	Standard Deviation 4.21
GW685698X 50 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n= 78, 84, 90, 97, 86, 83	72.6 Grams per liter (g/L)	Standard Deviation 4.62
GW685698X 50 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=94, 97, 99, 106, 94, 101	73.1 Grams per liter (g/L)	Standard Deviation 4.6
GW685698X 50 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n= 78, 84, 90, 97, 86, 83	44.9 Grams per liter (g/L)	Standard Deviation 2.97
GW685698X 50 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=94, 97, 99, 106, 94, 101	45.1 Grams per liter (g/L)	Standard Deviation 2.86
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=94, 97, 99, 106, 94, 101	45.9 Grams per liter (g/L)	Standard Deviation 3
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n= 78, 84, 90, 97, 86, 83	73.4 Grams per liter (g/L)	Standard Deviation 4.58
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n= 78, 84, 90, 97, 86, 83	45.6 Grams per liter (g/L)	Standard Deviation 2.91
GW685698X 100 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=94, 97, 99, 106, 94, 101	74.1 Grams per liter (g/L)	Standard Deviation 4.63
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=94, 97, 99, 106, 94, 101	73.4 Grams per liter (g/L)	Standard Deviation 4.5
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n= 78, 84, 90, 97, 86, 83	72.0 Grams per liter (g/L)	Standard Deviation 4.66
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n= 78, 84, 90, 97, 86, 83	44.5 Grams per liter (g/L)	Standard Deviation 3.22
GW685698X 200 µg OD	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=94, 97, 99, 106, 94, 101	45.3 Grams per liter (g/L)	Standard Deviation 2.96
FP 100 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin, W8, n= 78, 84, 90, 97, 86, 83	44.9 Grams per liter (g/L)	Standard Deviation 2.62
FP 100 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, BL, n=94, 97, 99, 106, 94, 101	73.2 Grams per liter (g/L)	Standard Deviation 4.23
FP 100 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Total protein, W8, n= 78, 84, 90, 97, 86, 83	72.5 Grams per liter (g/L)	Standard Deviation 4.05
FP 100 µg BID	Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8	Albumin,BL, n=94, 97, 99, 106, 94, 101	45.2 Grams per liter (g/L)	Standard Deviation 3.01

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

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=78, 84, 90, 97, 86, 83	22.3 International units per liter (IU/L)	Standard Deviation 22.79
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=94, 97, 99, 106, 94, 101	21.8 International units per liter (IU/L)	Standard Deviation 15.91
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=78, 84, 90, 97, 86, 83	29.7 International units per liter (IU/L)	Standard Deviation 27.53
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=94, 97, 99, 106, 94, 101	27.6 International units per liter (IU/L)	Standard Deviation 20
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=78, 83, 90, 97, 86, 82	151.8 International units per liter (IU/L)	Standard Deviation 32.37
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, BL, n=94, 96, 99, 105, 93, 101	157.9 International units per liter (IU/L)	Standard Deviation 47.78
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=78, 84, 90, 97, 85, 83	83.0 International units per liter (IU/L)	Standard Deviation 40.83
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=94, 97, 99, 106, 94, 101	82.7 International units per liter (IU/L)	Standard Deviation 36.11
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=78, 83, 90, 97, 86, 82	22.2 International units per liter (IU/L)	Standard Deviation 10.76
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=94, 96, 99, 105, 93, 101	21.0 International units per liter (IU/L)	Standard Deviation 7.64
GW685698X 25 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=78, 84, 90, 97, 85, 83	74.8 International units per liter (IU/L)	Standard Deviation 27.91
GW685698X 25 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=94, 97, 99, 106, 94, 101	79.7 International units per liter (IU/L)	Standard Deviation 32.21
GW685698X 25 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=94, 97, 99, 106, 94, 101	21.5 International units per liter (IU/L)	Standard Deviation 14.57
GW685698X 25 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=78, 84, 90, 97, 86, 83	20.3 International units per liter (IU/L)	Standard Deviation 11.92
GW685698X 25 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=94, 96, 99, 105, 93, 101	22.8 International units per liter (IU/L)	Standard Deviation 11.39
GW685698X 25 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=78, 83, 90, 97, 86, 82	20.8 International units per liter (IU/L)	Standard Deviation 6.48
GW685698X 25 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=94, 96, 99, 105, 93, 101	170.7 International units per liter (IU/L)	Standard Deviation 59.82
GW685698X 25 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=78, 83, 90, 97, 86, 82	159.1 International units per liter (IU/L)	Standard Deviation 31.46
GW685698X 25 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=94, 97, 99, 106, 94, 101	33.0 International units per liter (IU/L)	Standard Deviation 30.67
GW685698X 25 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=78, 84, 90, 97, 86, 83	31.1 International units per liter (IU/L)	Standard Deviation 24.61
GW685698X 50 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=78, 84, 90, 97, 86, 83	20.7 International units per liter (IU/L)	Standard Deviation 10.39
GW685698X 50 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=78, 83, 90, 97, 86, 82	159.9 International units per liter (IU/L)	Standard Deviation 32.14
GW685698X 50 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=94, 97, 99, 106, 94, 101	83.5 International units per liter (IU/L)	Standard Deviation 40.07
GW685698X 50 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=94, 96, 99, 105, 93, 101	22.8 International units per liter (IU/L)	Standard Deviation 13.35
GW685698X 50 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=94, 97, 99, 106, 94, 101	23.6 International units per liter (IU/L)	Standard Deviation 19.4
GW685698X 50 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=78, 84, 90, 97, 85, 83	82.9 International units per liter (IU/L)	Standard Deviation 41.61
GW685698X 50 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=78, 83, 90, 97, 86, 82	21.1 International units per liter (IU/L)	Standard Deviation 7.52
GW685698X 50 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=94, 97, 99, 106, 94, 101	33.1 International units per liter (IU/L)	Standard Deviation 31.42
GW685698X 50 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=78, 84, 90, 97, 86, 83	32.4 International units per liter (IU/L)	Standard Deviation 30.84
GW685698X 50 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=94, 96, 99, 105, 93, 101	169.3 International units per liter (IU/L)	Standard Deviation 64.08
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=94, 96, 99, 105, 93, 101	165.6 International units per liter (IU/L)	Standard Deviation 70.56
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=78, 83, 90, 97, 86, 82	153.8 International units per liter (IU/L)	Standard Deviation 26.9
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=78, 84, 90, 97, 85, 83	87.0 International units per liter (IU/L)	Standard Deviation 49.65
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=78, 84, 90, 97, 86, 83	31.9 International units per liter (IU/L)	Standard Deviation 24.96
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=94, 97, 99, 106, 94, 101	30.1 International units per liter (IU/L)	Standard Deviation 22.29
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=94, 97, 99, 106, 94, 101	90.3 International units per liter (IU/L)	Standard Deviation 56.43
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=78, 83, 90, 97, 86, 82	20.5 International units per liter (IU/L)	Standard Deviation 8.07
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=94, 96, 99, 105, 93, 101	21.9 International units per liter (IU/L)	Standard Deviation 9.68
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=78, 84, 90, 97, 86, 83	20.8 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	ALT, BL, n=94, 97, 99, 106, 94, 101	22.3 International units per liter (IU/L)	Standard Deviation 16.61
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=94, 96, 99, 105, 93, 101	172.9 International units per liter (IU/L)	Standard Deviation 62.38
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=78, 84, 90, 97, 86, 83	19.5 International units per liter (IU/L)	Standard Deviation 12.03
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=94, 96, 99, 105, 93, 101	21.3 International units per liter (IU/L)	Standard Deviation 7.2
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=78, 83, 90, 97, 86, 82	20.2 International units per liter (IU/L)	Standard Deviation 5.91
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=94, 97, 99, 106, 94, 101	94.4 International units per liter (IU/L)	Standard Deviation 71.94
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=78, 83, 90, 97, 86, 82	161.9 International units per liter (IU/L)	Standard Deviation 36.79
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=78, 84, 90, 97, 86, 83	29.3 International units per liter (IU/L)	Standard Deviation 32.75
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=94, 97, 99, 106, 94, 101	29.9 International units per liter (IU/L)	Standard Deviation 26.3
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=94, 97, 99, 106, 94, 101	20.7 International units per liter (IU/L)	Standard Deviation 11.38
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=78, 84, 90, 97, 85, 83	90.8 International units per liter (IU/L)	Standard Deviation 76.22
FP 100 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=78, 83, 90, 97, 86, 82	20.5 International units per liter (IU/L)	Standard Deviation 5.38
FP 100 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=78, 84, 90, 97, 86, 83	27.9 International units per liter (IU/L)	Standard Deviation 21.24
FP 100 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=78, 84, 90, 97, 85, 83	84.0 International units per liter (IU/L)	Standard Deviation 59.81
FP 100 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=94, 97, 99, 106, 94, 101	20.1 International units per liter (IU/L)	Standard Deviation 9.84
FP 100 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=94, 96, 99, 105, 93, 101	20.3 International units per liter (IU/L)	Standard Deviation 5.1
FP 100 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=94, 96, 99, 105, 93, 101	164.2 International units per liter (IU/L)	Standard Deviation 57.04
FP 100 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=78, 84, 90, 97, 86, 83	19.9 International units per liter (IU/L)	Standard Deviation 10.04
FP 100 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=78, 83, 90, 97, 86, 82	157.3 International units per liter (IU/L)	Standard Deviation 27.36
FP 100 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=94, 97, 99, 106, 94, 101	84.7 International units per liter (IU/L)	Standard Deviation 62.31
FP 100 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=94, 97, 99, 106, 94, 101	28.2 International units per liter (IU/L)	Standard Deviation 21.4

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 at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8

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	Calcium, W8, n=78, 83, 90, 97, 85, 82	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.1
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=94, 97, 99, 106, 94, 101	5.4 Millimoles per liter (mmol/L)	Standard Deviation 1.75
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=78, 83, 90, 97, 86, 82	23.1 Millimoles per liter (mmol/L)	Standard Deviation 2.57
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=94, 96, 99, 105, 93, 101	23.2 Millimoles per liter (mmol/L)	Standard Deviation 2.58
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=78, 84, 90, 97, 86, 83	140.7 Millimoles per liter (mmol/L)	Standard Deviation 2.09
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	Sodium, BL, n=94, 97, 99, 106, 94, 101	140.8 Millimoles per liter (mmol/L)	Standard Deviation 1.82
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=78, 84, 90, 97, 86, 83	104.8 Millimoles per liter (mmol/L)	Standard Deviation 2.24
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=78, 84, 90, 97, 86, 83	5.5 Millimoles per liter (mmol/L)	Standard Deviation 1.68
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=78, 83, 90, 97, 85, 82	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.34
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=94, 96, 99, 105, 93, 101	4.1 Millimoles per liter (mmol/L)	Standard Deviation 0.39
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=78, 84, 90, 97, 86, 83	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=94, 97, 99, 106, 94, 101	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.22
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=94, 96, 99, 105, 93, 101	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.1
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=94, 97, 99, 106, 94, 101	104.4 Millimoles per liter (mmol/L)	Standard Deviation 2.25
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=78, 84, 90, 97, 86, 83	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.07
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=94, 97, 99, 106, 94, 101	5.2 Millimoles per liter (mmol/L)	Standard Deviation 0.99
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=78, 84, 90, 97, 86, 83	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.24
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=94, 97, 99, 106, 94, 101	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.02
GW685698X 25 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=94, 96, 99, 105, 93, 101	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.1
GW685698X 25 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=94, 97, 99, 106, 94, 101	104.7 Millimoles per liter (mmol/L)	Standard Deviation 2.38
GW685698X 25 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=78, 84, 90, 97, 86, 83	104.8 Millimoles per liter (mmol/L)	Standard Deviation 2.36
GW685698X 25 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=78, 83, 90, 97, 85, 82	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.1
GW685698X 25 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=94, 96, 99, 105, 93, 101	22.8 Millimoles per liter (mmol/L)	Standard Deviation 2.71
GW685698X 25 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=78, 83, 90, 97, 86, 82	22.8 Millimoles per liter (mmol/L)	Standard Deviation 2.62
GW685698X 25 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=94, 97, 99, 106, 94, 101	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.04
GW685698X 25 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=78, 84, 90, 97, 86, 83	4.9 Millimoles per liter (mmol/L)	Standard Deviation 1.05
GW685698X 25 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=94, 97, 99, 106, 94, 101	5.5 Millimoles per liter (mmol/L)	Standard Deviation 2.05
GW685698X 25 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=78, 84, 90, 97, 86, 83	5.4 Millimoles per liter (mmol/L)	Standard Deviation 1.96
GW685698X 25 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=94, 97, 99, 106, 94, 101	1.1 Millimoles per liter (mmol/L)	Standard Deviation 0.2
GW685698X 25 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=78, 84, 90, 97, 86, 83	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.17
GW685698X 25 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=94, 96, 99, 105, 93, 101	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.44
GW685698X 25 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=78, 83, 90, 97, 85, 82	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.41
GW685698X 25 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=94, 97, 99, 106, 94, 101	140.5 Millimoles per liter (mmol/L)	Standard Deviation 2.05
GW685698X 25 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=78, 84, 90, 97, 86, 83	140.5 Millimoles per liter (mmol/L)	Standard Deviation 2.01
GW685698X 25 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=94, 97, 99, 106, 94, 101	5.3 Millimoles per liter (mmol/L)	Standard Deviation 1.66
GW685698X 25 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=78, 84, 90, 97, 86, 83	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.97
GW685698X 50 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=94, 96, 99, 105, 93, 101	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.09
GW685698X 50 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=78, 83, 90, 97, 85, 82	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.1
GW685698X 50 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=78, 84, 90, 97, 86, 83	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.2
GW685698X 50 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=94, 96, 99, 105, 93, 101	23.0 Millimoles per liter (mmol/L)	Standard Deviation 2.31
GW685698X 50 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=94, 97, 99, 106, 94, 101	104.5 Millimoles per liter (mmol/L)	Standard Deviation 2.5
GW685698X 50 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=78, 84, 90, 97, 86, 83	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.18
GW685698X 50 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=94, 97, 99, 106, 94, 101	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.17
GW685698X 50 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=78, 84, 90, 97, 86, 83	140.7 Millimoles per liter (mmol/L)	Standard Deviation 2.02
GW685698X 50 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=78, 84, 90, 97, 86, 83	5.1 Millimoles per liter (mmol/L)	Standard Deviation 1.05
GW685698X 50 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=94, 97, 99, 106, 94, 101	140.6 Millimoles per liter (mmol/L)	Standard Deviation 1.92
GW685698X 50 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=78, 84, 90, 97, 86, 83	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.3
GW685698X 50 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=78, 83, 90, 97, 85, 82	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.32
GW685698X 50 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=94, 97, 99, 106, 94, 101	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.14
GW685698X 50 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=94, 97, 99, 106, 94, 101	5.3 Millimoles per liter (mmol/L)	Standard Deviation 1.92
GW685698X 50 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=94, 97, 99, 106, 94, 101	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.18
GW685698X 50 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=78, 83, 90, 97, 86, 82	22.7 Millimoles per liter (mmol/L)	Standard Deviation 2.61
GW685698X 50 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=78, 84, 90, 97, 86, 83	104.7 Millimoles per liter (mmol/L)	Standard Deviation 2.55
GW685698X 50 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=94, 96, 99, 105, 93, 101	4.1 Millimoles per liter (mmol/L)	Standard Deviation 0.38
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=78, 84, 90, 97, 86, 83	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.16
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=94, 97, 99, 106, 94, 101	104.4 Millimoles per liter (mmol/L)	Standard Deviation 2.41
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=94, 97, 99, 106, 94, 101	5.0 Millimoles per liter (mmol/L)	Standard Deviation 0.97
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=94, 96, 99, 105, 93, 101	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.11
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=94, 97, 99, 106, 94, 101	5.1 Millimoles per liter (mmol/L)	Standard Deviation 0.89
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=94, 97, 99, 106, 94, 101	5.7 Millimoles per liter (mmol/L)	Standard Deviation 1.94
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	Glucose, W8, n=78, 84, 90, 97, 86, 83	5.0 Millimoles per liter (mmol/L)	Standard Deviation 0.88
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=94, 97, 99, 106, 94, 101	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	PI, W8, n=78, 84, 90, 97, 86, 83	1.3 Millimoles per liter (mmol/L)	Standard Deviation 0.2
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=78, 84, 90, 97, 86, 83	104.2 Millimoles per liter (mmol/L)	Standard Deviation 2.15
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=94, 96, 99, 105, 93, 101	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.4
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	Potassium, W8, n=78, 83, 90, 97, 85, 82	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.38
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=94, 97, 99, 106, 94, 101	140.8 Millimoles per liter (mmol/L)	Standard Deviation 2.16
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=78, 84, 90, 97, 86, 83	5.5 Millimoles per liter (mmol/L)	Standard Deviation 1.44
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=78, 84, 90, 97, 86, 83	140.6 Millimoles per liter (mmol/L)	Standard Deviation 1.63
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=78, 83, 90, 97, 85, 82	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.1
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=94, 96, 99, 105, 93, 101	23.4 Millimoles per liter (mmol/L)	Standard Deviation 2.49
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=78, 83, 90, 97, 86, 82	23.3 Millimoles per liter (mmol/L)	Standard Deviation 2.55
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=78, 83, 90, 97, 86, 82	22.7 Millimoles per liter (mmol/L)	Standard Deviation 2.42
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=78, 84, 90, 97, 86, 83	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.21
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=94, 96, 99, 105, 93, 101	23.5 Millimoles per liter (mmol/L)	Standard Deviation 2.45
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=94, 96, 99, 105, 93, 101	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.45
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=94, 97, 99, 106, 94, 101	5.1 Millimoles per liter (mmol/L)	Standard Deviation 0.83
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=78, 83, 90, 97, 85, 82	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.38
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=78, 84, 90, 97, 86, 83	5.0 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	Sodium, BL, n=94, 97, 99, 106, 94, 101	141.1 Millimoles per liter (mmol/L)	Standard Deviation 1.91
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=94, 97, 99, 106, 94, 101	104.8 Millimoles per liter (mmol/L)	Standard Deviation 2.17
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=78, 84, 90, 97, 86, 83	5.2 Millimoles per liter (mmol/L)	Standard Deviation 1.54
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=94, 97, 99, 106, 94, 101	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.08
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=78, 83, 90, 97, 85, 82	2.4 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	BUN, BL, n=94, 97, 99, 106, 94, 101	5.7 Millimoles per liter (mmol/L)	Standard Deviation 2.09
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=78, 84, 90, 97, 86, 83	140.9 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	PI, BL, n=94, 97, 99, 106, 94, 101	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.21
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=78, 84, 90, 97, 86, 83	104.7 Millimoles per liter (mmol/L)	Standard Deviation 2.11
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	Calcium, BL, n=94, 96, 99, 105, 93, 101	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.13
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	PI, W8, n=78, 84, 90, 97, 86, 83	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.21
FP 100 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=78, 84, 90, 97, 86, 83	104.6 Millimoles per liter (mmol/L)	Standard Deviation 2.67
FP 100 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=78, 84, 90, 97, 86, 83	140.8 Millimoles per liter (mmol/L)	Standard Deviation 1.97
FP 100 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=94, 97, 99, 106, 94, 101	5.3 Millimoles per liter (mmol/L)	Standard Deviation 1.54
FP 100 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=94, 97, 99, 106, 94, 101	5.4 Millimoles per liter (mmol/L)	Standard Deviation 1.72
FP 100 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=78, 84, 90, 97, 86, 83	5.1 Millimoles per liter (mmol/L)	Standard Deviation 1.18
FP 100 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=94, 96, 99, 105, 93, 101	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.4
FP 100 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=94, 97, 99, 106, 94, 101	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.18
FP 100 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=78, 84, 90, 97, 86, 83	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.43
FP 100 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=78, 84, 90, 97, 86, 83	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.07
FP 100 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=94, 96, 99, 105, 93, 101	23.5 Millimoles per liter (mmol/L)	Standard Deviation 2.74
FP 100 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=78, 83, 90, 97, 85, 82	2.4 Millimoles per liter (mmol/L)	Standard Deviation 0.09
FP 100 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=78, 83, 90, 97, 85, 82	4.2 Millimoles per liter (mmol/L)	Standard Deviation 0.36
FP 100 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=94, 97, 99, 106, 94, 101	104.4 Millimoles per liter (mmol/L)	Standard Deviation 2.49
FP 100 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=78, 83, 90, 97, 86, 82	22.8 Millimoles per liter (mmol/L)	Standard Deviation 2.6
FP 100 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=94, 96, 99, 105, 93, 101	2.3 Millimoles per liter (mmol/L)	Standard Deviation 0.09
FP 100 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=94, 97, 99, 106, 94, 101	5.0 Millimoles per liter (mmol/L)	Standard Deviation 1.1
FP 100 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=78, 84, 90, 97, 86, 83	1.2 Millimoles per liter (mmol/L)	Standard Deviation 0.2
FP 100 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=94, 97, 99, 106, 94, 101	140.8 Millimoles per liter (mmol/L)	Standard Deviation 2.04

Secondary

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

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

Time frame: Baseline and Week 8

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, BL, n=94, 97, 99, 106, 94, 101	9.6 Micromoles per liter (µmol/L)	Standard Deviation 6.1
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, W8, n=77, 84, 89, 97, 86, 83	2.0 Micromoles per liter (µmol/L)	Standard Deviation 1.03
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, BL, n=94, 97, 99, 106, 94, 101	2.1 Micromoles per liter (µmol/L)	Standard Deviation 1.26
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, W8, n=78, 84, 90, 97, 86, 83	10.3 Micromoles per liter (µmol/L)	Standard Deviation 5.57
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, BL, n=94, 97, 99, 105, 94, 101	337.8 Micromoles per liter (µmol/L)	Standard Deviation 88.15
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, W8, n=78, 84, 90, 96, 86, 83	353.6 Micromoles per liter (µmol/L)	Standard Deviation 86.64
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, BL, n=94, 97, 99, 106, 94, 101	83.2 Micromoles per liter (µmol/L)	Standard Deviation 19.89
Placebo	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, W8, n=78, 84, 90, 97, 86, 83	84.5 Micromoles per liter (µmol/L)	Standard Deviation 19.21
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, W8, n=78, 84, 90, 97, 86, 83	9.1 Micromoles per liter (µmol/L)	Standard Deviation 4.14
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, W8, n=78, 84, 90, 97, 86, 83	79.7 Micromoles per liter (µmol/L)	Standard Deviation 15.67
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, BL, n=94, 97, 99, 106, 94, 101	2.1 Micromoles per liter (µmol/L)	Standard Deviation 1.29
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, BL, n=94, 97, 99, 106, 94, 101	79.8 Micromoles per liter (µmol/L)	Standard Deviation 14.72
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, W8, n=78, 84, 90, 96, 86, 83	327.5 Micromoles per liter (µmol/L)	Standard Deviation 84.69
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, BL, n=94, 97, 99, 106, 94, 101	9.7 Micromoles per liter (µmol/L)	Standard Deviation 6.08
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, W8, n=77, 84, 89, 97, 86, 83	2.0 Micromoles per liter (µmol/L)	Standard Deviation 0.94
GW685698X 25 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, BL, n=94, 97, 99, 105, 94, 101	327.2 Micromoles per liter (µmol/L)	Standard Deviation 85.64
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, W8, n=77, 84, 89, 97, 86, 83	1.9 Micromoles per liter (µmol/L)	Standard Deviation 0.98
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, BL, n=94, 97, 99, 106, 94, 101	9.0 Micromoles per liter (µmol/L)	Standard Deviation 4.39
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, W8, n=78, 84, 90, 97, 86, 83	8.7 Micromoles per liter (µmol/L)	Standard Deviation 3.99
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, W8, n=78, 84, 90, 97, 86, 83	79.0 Micromoles per liter (µmol/L)	Standard Deviation 13.45
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, BL, n=94, 97, 99, 105, 94, 101	325.6 Micromoles per liter (µmol/L)	Standard Deviation 85.82
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, W8, n=78, 84, 90, 96, 86, 83	321.9 Micromoles per liter (µmol/L)	Standard Deviation 91.9
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, BL, n=94, 97, 99, 106, 94, 101	77.7 Micromoles per liter (µmol/L)	Standard Deviation 14.52
GW685698X 50 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, BL, n=94, 97, 99, 106, 94, 101	2.0 Micromoles per liter (µmol/L)	Standard Deviation 1.04
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, BL, n=94, 97, 99, 106, 94, 101	81.9 Micromoles per liter (µmol/L)	Standard Deviation 16.68
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, W8, n=78, 84, 90, 96, 86, 83	340.9 Micromoles per liter (µmol/L)	Standard Deviation 89.48
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, BL, n=94, 97, 99, 105, 94, 101	334.1 Micromoles per liter (µmol/L)	Standard Deviation 90.63
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, BL, n=94, 97, 99, 106, 94, 101	2.0 Micromoles per liter (µmol/L)	Standard Deviation 1.13
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, BL, n=94, 97, 99, 106, 94, 101	9.3 Micromoles per liter (µmol/L)	Standard Deviation 4.35
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, W8, n=78, 84, 90, 97, 86, 83	9.1 Micromoles per liter (µmol/L)	Standard Deviation 3.88
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, W8, n=78, 84, 90, 97, 86, 83	81.7 Micromoles per liter (µmol/L)	Standard Deviation 14.9
GW685698X 100 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, W8, n=77, 84, 89, 97, 86, 83	1.9 Micromoles per liter (µmol/L)	Standard Deviation 1.02
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, W8, n=78, 84, 90, 97, 86, 83	77.7 Micromoles per liter (µmol/L)	Standard Deviation 14.32
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, BL, n=94, 97, 99, 106, 94, 101	1.8 Micromoles per liter (µmol/L)	Standard Deviation 1.17
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, BL, n=94, 97, 99, 105, 94, 101	326.6 Micromoles per liter (µmol/L)	Standard Deviation 85.37
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, W8, n=78, 84, 90, 96, 86, 83	316.5 Micromoles per liter (µmol/L)	Standard Deviation 81.29
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, BL, n=94, 97, 99, 106, 94, 101	78.3 Micromoles per liter (µmol/L)	Standard Deviation 15.21
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, W8, n=77, 84, 89, 97, 86, 83	1.7 Micromoles per liter (µmol/L)	Standard Deviation 0.93
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, BL, n=94, 97, 99, 106, 94, 101	8.7 Micromoles per liter (µmol/L)	Standard Deviation 4.11
GW685698X 200 µg OD	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, W8, n=78, 84, 90, 97, 86, 83	8.5 Micromoles per liter (µmol/L)	Standard Deviation 3.46
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, W8, n=78, 84, 90, 97, 86, 83	80.4 Micromoles per liter (µmol/L)	Standard Deviation 15.97
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, BL, n=94, 97, 99, 105, 94, 101	324.5 Micromoles per liter (µmol/L)	Standard Deviation 78.64
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, BL, n=94, 97, 99, 106, 94, 101	9.0 Micromoles per liter (µmol/L)	Standard Deviation 3.93
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	TBIL, W8, n=78, 84, 90, 97, 86, 83	9.4 Micromoles per liter (µmol/L)	Standard Deviation 4.39
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Uric acid, W8, n=78, 84, 90, 96, 86, 83	325.4 Micromoles per liter (µmol/L)	Standard Deviation 80.48
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, W8, n=77, 84, 89, 97, 86, 83	1.9 Micromoles per liter (µmol/L)	Standard Deviation 1.05
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	Creatinine, BL, n=94, 97, 99, 106, 94, 101	79.3 Micromoles per liter (µmol/L)	Standard Deviation 15.08
FP 100 µg BID	Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8	DBIL, BL, n=94, 97, 99, 106, 94, 101	2.0 Micromoles per liter (µmol/L)	Standard Deviation 1.04

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 (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	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=72, 79, 83, 94, 82, 79	0.43 Proportion of 1	Standard Deviation 0.038
Placebo	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=92, 94, 95, 106, 92, 97	0.43 Proportion of 1	Standard Deviation 0.041
GW685698X 25 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=72, 79, 83, 94, 82, 79	0.42 Proportion of 1	Standard Deviation 0.038
GW685698X 25 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=92, 94, 95, 106, 92, 97	0.42 Proportion of 1	Standard Deviation 0.039
GW685698X 50 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=72, 79, 83, 94, 82, 79	0.42 Proportion of 1	Standard Deviation 0.037
GW685698X 50 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=92, 94, 95, 106, 92, 97	0.42 Proportion of 1	Standard Deviation 0.04
GW685698X 100 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=92, 94, 95, 106, 92, 97	0.43 Proportion of 1	Standard Deviation 0.043
GW685698X 100 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=72, 79, 83, 94, 82, 79	0.43 Proportion of 1	Standard Deviation 0.04
GW685698X 200 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=92, 94, 95, 106, 92, 97	0.42 Proportion of 1	Standard Deviation 0.039
GW685698X 200 µg OD	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=72, 79, 83, 94, 82, 79	0.42 Proportion of 1	Standard Deviation 0.033
FP 100 µg BID	Hematocrit at Baseline and Week 8	Hematocrit, W8, n=72, 79, 83, 94, 82, 79	0.43 Proportion of 1	Standard Deviation 0.039
FP 100 µg BID	Hematocrit at Baseline and Week 8	Hematocrit, BL, n=92, 94, 95, 106, 92, 97	0.43 Proportion of 1	Standard Deviation 0.034

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 (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	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=92, 94, 95, 106, 92, 96	141.54 Grams per liter (G/L)	Standard Deviation 14.116
Placebo	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=72, 79, 83, 94, 82, 79	140.81 Grams per liter (G/L)	Standard Deviation 12.973
GW685698X 25 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=92, 94, 95, 106, 92, 96	138.05 Grams per liter (G/L)	Standard Deviation 13.178
GW685698X 25 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=72, 79, 83, 94, 82, 79	137.86 Grams per liter (G/L)	Standard Deviation 12.862
GW685698X 50 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=92, 94, 95, 106, 92, 96	140.70 Grams per liter (G/L)	Standard Deviation 13.769
GW685698X 50 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=72, 79, 83, 94, 82, 79	138.95 Grams per liter (G/L)	Standard Deviation 12.785
GW685698X 100 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=92, 94, 95, 106, 92, 96	141.14 Grams per liter (G/L)	Standard Deviation 14.625
GW685698X 100 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=72, 79, 83, 94, 82, 79	140.16 Grams per liter (G/L)	Standard Deviation 13.647
GW685698X 200 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=92, 94, 95, 106, 92, 96	139.50 Grams per liter (G/L)	Standard Deviation 12.978
GW685698X 200 µg OD	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=72, 79, 83, 94, 82, 79	136.32 Grams per liter (G/L)	Standard Deviation 11.594
FP 100 µg BID	Hemoglobin at Baseline and Week 8	Hemoglobin, BL, n=92, 94, 95, 106, 92, 96	141.90 Grams per liter (G/L)	Standard Deviation 11.632
FP 100 µg BID	Hemoglobin at Baseline and Week 8	Hemoglobin, W8, n=72, 79, 83, 94, 82, 79	139.81 Grams per liter (G/L)	Standard Deviation 13.009

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 th 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	13.6 Liters per minute	Standard Error 4.27
GW685698X 25 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	27.2 Liters per minute	Standard Error 4.23
GW685698X 50 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	33.5 Liters per minute	Standard Error 4.17
GW685698X 100 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	29.5 Liters per minute	Standard Error 3.95
GW685698X 200 µg OD	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	35.6 Liters per minute	Standard Error 4.26
FP 100 µg BID	Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	25.6 Liters per minute	Standard Error 4.09

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	9.6 Liters per minute	Standard Error 4.21
GW685698X 25 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	23.6 Liters per minute	Standard Error 4.17
GW685698X 50 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	30.3 Liters per minute	Standard Error 4.12
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	25.7 Liters per minute	Standard Error 3.9
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	31.3 Liters per minute	Standard Error 4.2
FP 100 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	24.4 Liters per minute	Standard Error 4.04

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-hour 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	21.9 Percentage of rescue-free 24-hr periods	Standard Error 3.32
GW685698X 25 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	29.3 Percentage of rescue-free 24-hr periods	Standard Error 3.28
GW685698X 50 µg OD	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 3.24
GW685698X 100 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	40.8 Percentage of rescue-free 24-hr periods	Standard Error 3.08
GW685698X 200 µg OD	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	32.0 Percentage of rescue-free 24-hr periods	Standard Error 3.31
FP 100 µg BID	Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period	35.5 Percentage of rescue-free 24-hr periods	Standard Error 3.18

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	18.4 Percentage of symptom-free 24-hr periods	Standard Error 3.21
GW685698X 25 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period	25.3 Percentage of symptom-free 24-hr periods	Standard Error 3.17
GW685698X 50 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period	31.1 Percentage of symptom-free 24-hr periods	Standard Error 3.14
GW685698X 100 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period	38.7 Percentage of symptom-free 24-hr periods	Standard Error 2.97
GW685698X 200 µg OD	Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period	31.7 Percentage of symptom-free 24-hr periods	Standard Error 3.2
FP 100 µg BID	Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period	33.3 Percentage of symptom-free 24-hr periods	Standard Error 3.08

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	14 participants
GW685698X 25 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	9 participants
GW685698X 50 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	3 participants
GW685698X 100 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	6 participants
GW685698X 200 µg OD	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	6 participants
FP 100 µg BID	Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period	11 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	24 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 25 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	19 participants
GW685698X 25 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 50 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	28 participants
GW685698X 50 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 100 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 100 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 200 µg OD	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	27 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
FP 100 µg BID	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any AE	35 participants
FP 100 µg BID	Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period	Any SAE	2 participants

Secondary

Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis

A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.

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	94 participants
GW685698X 25 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	0 participants
GW685698X 25 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	97 participants
GW685698X 50 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	4 participants
GW685698X 50 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	96 participants
GW685698X 100 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	4 participants
GW685698X 100 µg OD	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	106 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	93 participants
FP 100 µg BID	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	Clinical evidence	2 participants
FP 100 µg BID	Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis	No clinical evidence	100 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 large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 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 (EW). The Baseline value was the measurement taken at screening (Visit 1).

Time frame: Baseline and Week 8/Early Withdrawal

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	UWBC, Mod, BL, n=92, 94, 95, 106, 93, 96	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, W8,n=71, 81, 82, 93, 82, 77	60 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, Mod, W8, n=71, 81, 82, 93, 82, 77	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, BL, n=92, 94, 95, 106, 93, 96	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, Trace, W8, n=71, 81, 82, 93, 82, 77	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	UWBC, Neg, W8, n=71, 81, 82, 93, 82, 77	66 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=92, 94, 95, 106, 93, 96	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	UP, 1+, W8, n=71, 81, 82, 93, 82, 77	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	UK, Neg, BL, n=92, 94, 95, 106, 93, 96	91 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=92, 94, 95, 106, 93, 96	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	UK, 2+, BL, n=92, 94, 95, 106, 93, 96	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, Small, W8, n=71, 81, 82, 93, 82, 77	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, BL, n=92, 94, 95, 106, 93, 96	88 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=92, 94, 95, 106, 93, 96	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, Large, W8, n=71, 81, 82, 93, 82, 77	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, 1+, BL, n=92, 94, 95, 106, 93, 96	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, EW, n=2, 1, 2, 3, 1, 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	UWBC, Trace, W8, n=71, 81, 82, 93, 82, 77	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, 1+, W8, n=71, 81, 82, 93, 82, 77	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+, BL, n=92, 94, 95, 106, 93, 96	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, Neg, EW, n=2, 1, 2, 3, 1, 7	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, Neg, BL, n=92, 94, 95, 106, 93, 96	79 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, W8, n=71, 81, 82, 93,82,77	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, 2+, EW, n=2, 1, 2, 3, 1, 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	UWBC, Trace, BL, n=92, 94, 95, , 93, 96	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, 3+, BL, n=92, 94, 95, 106, 93, 96	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, W8, n=71, 81, 82, 93, 82, 77	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, Trace, W8, n=71, 81, 82, 93, 82, 77	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+, BL, n=92, 94, 95, 106, 93, 96	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, Neg, EW, n=2, 1, 2, 3, 1, 7	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, 3+, W8, n=71, 81, 82, 93, 82, 77	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=71, 81, 82, 93, 82, 77	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, Neg, W8, n=71, 81, 82, 93, 82, 77	71 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, EW, n=2, 1, 2, 3, 1, 7	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	UG, 3+ or 1 G/DL, W8, n=71, 81, 82, 93, 82, 77	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, 1+, W8, n=71, 81, 82, 93, 82, 77	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, Trace, W8, n=71, 81, 82, 93, 82, 77	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, 1+ or 1/4 G/DL, W8, n=71, 81, 82, 93, 82, 77	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+, W8, n=71, 81, 82, 93, 82, 77	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	UOB, 2+, BL, n=92, 94, 95, 106, 93, 96	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	UOB, Trace, BL, n=92, 94, 95, 106, 93, 96	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	UP, 2+, W8, n=71, 81, 82, 93, 82, 77	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	UG, Trace or 1/10 G/DL, BL, n=92, 94, 95,106,93,96	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	UK, Trace, W8, n=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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, 3+, BL, n=92, 94, 95, 106, 93, 96	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, Small, BL, n=92, 94, 95, 106, 93, 96	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, 2+, BL, n=92, 94, 95, 106, 93, 96	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, 2+, W8, n=71, 81, 82, 93, 82, 77	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=92, 94, 95, 106, 93, 96	90 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=92, 94, 95, 106, 93, 96	14 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, 4+, BL, n=92, 94, 95, 106, 93, 96	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, EW, n=2, 1, 2, 3, 1, 7	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, Neg, W8, n=71, 81, 82, 93, 82, 77	67 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, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96	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=92, 94, 95, 106, 93, 96	70 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=92, 94, 95, 106, 93, 96	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, Mod, BL, n=92, 94, 95, 106, 93, 96	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	UK, 2+, W8, n=71, 81, 82, 93, 82, 77	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, EW, n=2, 1, 2, 3, 1, 7, 1, 7	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, 3+, W8, n=71, 81, 82, 93, 82, 77	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, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	91 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	2 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	4 participants
GW685698X 25 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, Small, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	71 participants
GW685698X 25 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, Mod, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	10 participants
GW685698X 25 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, Large, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	3 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	2 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	3 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	8 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	76 participants
GW685698X 25 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, Mod, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	84 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	7 participants
GW685698X 25 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=92, 94, 95, , 93, 96	3 participants
GW685698X 25 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, EW, n=2, 1, 2, 3, 1, 7	0 participants
GW685698X 25 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, EW, n=2, 1, 2, 3, 1, 7	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	3 participants
GW685698X 25 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, EW, n=2, 1, 2, 3, 1, 7, 1, 7	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	4 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	77 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	70 participants
GW685698X 25 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+, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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, EW, n=2, 1, 2, 3, 1, 7	1 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	5 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	89 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	71 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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, Small, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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, EW, n=2, 1, 2, 3, 1, 7	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	6 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 25 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, W8, n=71, 81, 82, 93,82,77	0 participants
GW685698X 25 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+, EW, n=2, 1, 2, 3, 1, 7	1 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	77 participants
GW685698X 25 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, EW, n=2, 1, 2, 3, 1, 7	0 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	3 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 25 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 25 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=92, 94, 95,106,93,96	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	91 participants
GW685698X 25 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, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96	1 participants
GW685698X 25 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, 4+, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	3 participants
GW685698X 25 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=92, 94, 95, 106, 93, 96	2 participants
GW685698X 25 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, Mod, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 25 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, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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, EW, n=2, 1, 2, 3, 1, 7, 1, 7	2 participants
GW685698X 50 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, EW, n=2, 1, 2, 3, 1, 7	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	6 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	2 participants
GW685698X 50 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, Mod, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	82 participants
GW685698X 50 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=92, 94, 95, , 93, 96	4 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	2 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	4 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	2 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	69 participants
GW685698X 50 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, Small, W8, n=71, 81, 82, 93, 82, 77	1 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	4 participants
GW685698X 50 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+, EW, n=2, 1, 2, 3, 1, 7	0 participants
GW685698X 50 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, EW, n=2, 1, 2, 3, 1, 7	2 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	3 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	2 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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, 4+, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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, Mod, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	83 participants
GW685698X 50 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, Small, BL, n=92, 94, 95, 106, 93, 96	3 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	4 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	2 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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, Large, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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, Mod, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	73 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	6 participants
GW685698X 50 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, EW, n=2, 1, 2, 3, 1, 7	2 participants
GW685698X 50 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, BL, n=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 50 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, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	94 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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=92, 94, 95,106,93,96	0 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	1 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	80 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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, W8, n=71, 81, 82, 93,82,77	0 participants
GW685698X 50 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, EW, n=2, 1, 2, 3, 1, 7	2 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	1 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	0 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	92 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	2 participants
GW685698X 50 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+, W8, n=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	78 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	4 participants
GW685698X 50 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, EW, n=2, 1, 2, 3, 1, 7	2 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	6 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	2 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	80 participants
GW685698X 50 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=92, 94, 95, 106, 93, 96	7 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	5 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	0 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	68 participants
GW685698X 50 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=71, 81, 82, 93, 82, 77	9 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=71, 81, 82, 93, 82, 77	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, EW, n=2, 1, 2, 3, 1, 7, 1, 7	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	UK, Neg, EW, n=2, 1, 2, 3, 1, 7	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, Neg, W8,n=71, 81, 82, 93, 82, 77	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	UOB, Trace, BL, n=92, 94, 95, 106, 93, 96	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, 1+, BL, n=92, 94, 95, 106, 93, 96	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 or 1/10 G/DL, W8, n=71, 81, 82, 93,82,77	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, BL, n=92, 94, 95, 106, 93, 96	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, Trace, W8, n=71, 81, 82, 93, 82, 77	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, Trace, W8, n=71, 81, 82, 93, 82, 77	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, 1+, W8, n=71, 81, 82, 93, 82, 77	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	UK, Neg, W8, n=71, 81, 82, 93, 82, 77	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	UG, Neg, EW, n=2, 1, 2, 3, 1, 7	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, 3+, BL, n=92, 94, 95, 106, 93, 96	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, EW, n=2, 1, 2, 3, 1, 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	UOB, Large, W8, n=71, 81, 82, 93, 82, 77	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, Small, W8, n=71, 81, 82, 93, 82, 77	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=92, 94, 95, 106, 93, 96	105 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=92, 94, 95, 106, 93, 96	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, 2+, BL, n=92, 94, 95, 106, 93, 96	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, 2+, W8, n=71, 81, 82, 93, 82, 77	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	UK, 2+, W8, n=71, 81, 82, 93, 82, 77	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	UP, Trace, BL, n=92, 94, 95, 106, 93, 96	8 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=71, 81, 82, 93, 82, 77	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=92, 94, 95, 106, 93, 96	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	UOB, 3+, W8, n=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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, Neg, W8, n=71, 81, 82, 93, 82, 77	81 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=71, 81, 82, 93, 82, 77	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, Trace, W8, n=71, 81, 82, 93, 82, 77	8 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=92, 94, 95, 106, 93, 96	104 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=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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, Neg, W8, n=71, 81, 82, 93, 82, 77	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	UOB, 2+, W8, n=71, 81, 82, 93, 82, 77	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, 2+, BL, n=92, 94, 95, 106, 93, 96	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+, BL, n=92, 94, 95, 106, 93, 96	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, BL, n=92, 94, 95, 106, 93, 96	97 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=92, 94, 95,106,93,96	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, 1+, W8, n=71, 81, 82, 93, 82, 77	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	UP, Neg, BL, n=92, 94, 95, 106, 93, 96	89 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=92, 94, 95, 106, 93, 96	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	UOB, 1+, BL, n=92, 94, 95, 106, 93, 96	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, Trace, W8, n=71, 81, 82, 93, 82, 77	13 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=71, 81, 82, 93, 82, 77	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	UOB, Neg, EW, n=2, 1, 2, 3, 1, 7	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, 3+, BL, n=92, 94, 95, 106, 93, 96	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, Mod, BL, n=92, 94, 95, 106, 93, 96	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	UOB, Small, BL, n=92, 94, 95, 106, 93, 96	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=71, 81, 82, 93, 82, 77	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, 3+ or 1 G/DL, W8, n=71, 81, 82, 93, 82, 77	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	UOB, 4+, BL, n=92, 94, 95, 106, 93, 96	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	UP, 2+, BL, n=92, 94, 95, 106, 93, 96	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, Neg, EW, n=2, 1, 2, 3, 1, 7	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	UWBC, Neg, BL, n=92, 94, 95, 106, 93, 96	92 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, Mod, W8, n=71, 81, 82, 93, 82, 77	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, W8, n=71, 81, 82, 93, 82, 77	92 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, Mod, BL, n=92, 94, 95, 106, 93, 96	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, 1+, BL, n=92, 94, 95, 106, 93, 96	8 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, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96	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, 2+, EW, n=2, 1, 2, 3, 1, 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, Trace, BL, n=92, 94, 95, , 93, 96	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	UK, Neg, BL, n=92, 94, 95, 106, 93, 96	90 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, EW, n=2, 1, 2, 3, 1, 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, Mod, BL, n=92, 94, 95, 106, 93, 96	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, 1+ or 1/4 G/DL, BL, n=92, 94, 95, 106, 93, 96	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, 4+, BL, n=92, 94, 95, 106, 93, 96	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, BL, n=92, 94, 95, 106, 93, 96	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, 1+, W8, n=71, 81, 82, 93, 82, 77	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	UG, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96	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, 3+, BL, n=92, 94, 95, 106, 93, 96	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, BL, n=92, 94, 95, 106, 93, 96	91 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=92, 94, 95, 106, 93, 96	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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, 1+, BL, n=92, 94, 95, 106, 93, 96	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	UG, Trace or 1/10 G/DL, BL, n=92, 94, 95,106,93,96	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, 1+, BL, n=92, 94, 95, 106, 93, 96	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	UG, 1+ or 1/4 G/DL, W8, n=71, 81, 82, 93, 82, 77	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, EW, n=2, 1, 2, 3, 1, 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	UG, 3+ or 1 G/DL, W8, n=71, 81, 82, 93, 82, 77	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, 2+, W8, n=71, 81, 82, 93, 82, 77	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, Neg, W8, n=71, 81, 82, 93, 82, 77	78 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+, EW, n=2, 1, 2, 3, 1, 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, Trace, W8, n=71, 81, 82, 93, 82, 77	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, Trace, W8, n=71, 81, 82, 93, 82, 77	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	UG, Trace or 1/10 G/DL, W8, n=71, 81, 82, 93,82,77	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, EW, n=2, 1, 2, 3, 1, 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, Small, W8, n=71, 81, 82, 93, 82, 77	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, W8, n=71, 81, 82, 93, 82, 77	12 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=92, 94, 95, 106, 93, 96	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, Neg, W8, n=71, 81, 82, 93, 82, 77	67 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=92, 94, 95, 106, 93, 96	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=71, 81, 82, 93, 82, 77	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, 3+, W8, n=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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, 2+, W8, n=71, 81, 82, 93, 82, 77	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	UP, Trace, EW, n=2, 1, 2, 3, 1, 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	UK, 2+, W8, n=71, 81, 82, 93, 82, 77	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=71, 81, 82, 93, 82, 77	79 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=71, 81, 82, 93, 82, 77	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	UK, Trace, W8, n=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, , 93, 96	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	UK, Neg, EW, n=2, 1, 2, 3, 1, 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, W8,n=71, 81, 82, 93, 82, 77	64 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=92, 94, 95, 106, 93, 96	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, Neg, BL, n=92, 94, 95, 106, 93, 96	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	UP, 2+, BL, n=92, 94, 95, 106, 93, 96	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, Mod, BL, n=92, 94, 95, 106, 93, 96	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+, BL, n=92, 94, 95, 106, 93, 96	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, 3+, BL, n=92, 94, 95, 106, 93, 96	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=92, 94, 95, 106, 93, 96	80 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=71, 81, 82, 93, 82, 77	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+, W8, n=71, 81, 82, 93, 82, 77	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	UP, Neg, EW, n=2, 1, 2, 3, 1, 7, 1, 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, 3+, W8, n=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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	UOB, Large, W8, n=71, 81, 82, 93, 82, 77	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, Trace, BL, n=92, 94, 95, 106, 93, 96	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	UOB, Mod, W8, n=71, 81, 82, 93, 82, 77	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, Small, BL, n=92, 94, 95, 106, 93, 96	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, W8, n=71, 81, 82, 93, 82, 77	69 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=92, 94, 95, 106, 93, 96	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	UWBC, 2+, BL, n=92, 94, 95, 106, 93, 96	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, W8, n=71, 81, 82, 93, 82, 77	5 participants
FP 100 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, EW, n=2, 1, 2, 3, 1, 7	7 participants
FP 100 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=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	85 participants
FP 100 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=71, 81, 82, 93, 82, 77	66 participants
FP 100 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=71, 81, 82, 93, 82, 77	76 participants
FP 100 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, Large, W8, n=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	4 participants
FP 100 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, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96	0 participants
FP 100 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+, EW, n=2, 1, 2, 3, 1, 7	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	71 participants
FP 100 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=71, 81, 82, 93, 82, 77	1 participants
FP 100 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, Small, BL, n=92, 94, 95, 106, 93, 96	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	0 participants
FP 100 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, Mod, BL, n=92, 94, 95, 106, 93, 96	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	82 participants
FP 100 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, EW, n=2, 1, 2, 3, 1, 7	6 participants
FP 100 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=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	2 participants
FP 100 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=92, 94, 95, 106, 93, 96	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	2 participants
FP 100 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, EW, n=2, 1, 2, 3, 1, 7	7 participants
FP 100 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, EW, n=2, 1, 2, 3, 1, 7, 1, 7	5 participants
FP 100 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=92, 94, 95,106,93,96	0 participants
FP 100 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, Mod, W8, n=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	78 participants
FP 100 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=92, 94, 95, 106, 93, 96	2 participants
FP 100 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=71, 81, 82, 93, 82, 77	3 participants
FP 100 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=92, 94, 95, 106, 93, 96	3 participants
FP 100 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=92, 94, 95, 106, 93, 96	0 participants
FP 100 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=71, 81, 82, 93, 82, 77	4 participants
FP 100 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=71, 81, 82, 93, 82, 77	3 participants
FP 100 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, Mod, BL, n=92, 94, 95, 106, 93, 96	1 participants
FP 100 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=92, 94, 95, 106, 93, 96	95 participants
FP 100 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=92, 94, 95, 106, 93, 96	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	3 participants
FP 100 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=92, 94, 95, 106, 93, 96	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	3 participants
FP 100 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=92, 94, 95, 106, 93, 96	14 participants
FP 100 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=92, 94, 95, 106, 93, 96	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	67 participants
FP 100 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, 4+, BL, n=92, 94, 95, 106, 93, 96	0 participants
FP 100 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+, W8, n=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=92, 94, 95, 106, 93, 96	0 participants
FP 100 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=71, 81, 82, 93, 82, 77	4 participants
FP 100 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, EW, n=2, 1, 2, 3, 1, 7	7 participants
FP 100 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, EW, n=2, 1, 2, 3, 1, 7	2 participants
FP 100 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=71, 81, 82, 93, 82, 77	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	69 participants
FP 100 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=92, 94, 95, 106, 93, 96	8 participants
FP 100 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, Small, W8, n=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=71, 81, 82, 93, 82, 77	4 participants
FP 100 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, W8, n=71, 81, 82, 93,82,77	0 participants
FP 100 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, BL, n=92, 94, 95, 106, 93, 96	1 participants
FP 100 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=71, 81, 82, 93, 82, 77	8 participants
FP 100 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=92, 94, 95, , 93, 96	3 participants
FP 100 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=92, 94, 95, 106, 93, 96	94 participants
FP 100 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=71, 81, 82, 93, 82, 77	2 participants
FP 100 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=71, 81, 82, 93, 82, 77	0 participants
FP 100 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=71, 81, 82, 93, 82, 77	2 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=72, 80, 83, 94, 82, 79	4.31 Percentage	Standard Deviation 3.544
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=92, 94, 95, 106, 92, 97	3.87 Percentage	Standard Deviation 3.022
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79	57.08 Percentage	Standard Deviation 9.543
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=92, 94, 95, 106, 92, 97	56.74 Percentage	Standard Deviation 9.22
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=72, 80, 83, 94, 82, 79	5.41 Percentage	Standard Deviation 3.042
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=92, 94, 95, 106, 92, 97	5.09 Percentage	Standard Deviation 2.379
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=72, 80, 83, 94, 82, 79	0.30 Percentage	Standard Deviation 0.186
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=92, 94, 95, 106, 92, 97	0.31 Percentage	Standard Deviation 0.199
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=72, 80, 83, 94, 82, 79	32.88 Percentage	Standard Deviation 8.063
Placebo	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=92, 94, 95, 106, 92, 97	33.96 Percentage	Standard Deviation 8.378
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=72, 80, 83, 94, 82, 79	0.26 Percentage	Standard Deviation 0.153
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=92, 94, 95, 106, 92, 97	0.32 Percentage	Standard Deviation 0.2
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=92, 94, 95, 106, 92, 97	3.38 Percentage	Standard Deviation 2.693
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=72, 80, 83, 94, 82, 79	3.38 Percentage	Standard Deviation 3.3
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=92, 94, 95, 106, 92, 97	31.57 Percentage	Standard Deviation 8.821
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=72, 80, 83, 94, 82, 79	29.82 Percentage	Standard Deviation 10.12
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=92, 94, 95, 106, 92, 97	4.41 Percentage	Standard Deviation 1.851
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=72, 80, 83, 94, 82, 79	4.32 Percentage	Standard Deviation 2.098
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=92, 94, 95, 106, 92, 97	60.24 Percentage	Standard Deviation 9.62
GW685698X 25 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79	62.19 Percentage	Standard Deviation 11.58
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=72, 80, 83, 94, 82, 79	3.76 Percentage	Standard Deviation 2.608
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=72, 80, 83, 94, 82, 79	4.60 Percentage	Standard Deviation 2.486
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=92, 94, 95, 106, 92, 97	0.31 Percentage	Standard Deviation 0.194
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=92, 94, 95, 106, 92, 97	33.33 Percentage	Standard Deviation 7.768
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=92, 94, 95, 106, 92, 97	3.95 Percentage	Standard Deviation 2.503
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=72, 80, 83, 94, 82, 79	0.31 Percentage	Standard Deviation 0.169
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=72, 80, 83, 94, 82, 79	30.36 Percentage	Standard Deviation 8.322
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=92, 94, 95, 106, 92, 97	57.68 Percentage	Standard Deviation 8.309
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79	60.95 Percentage	Standard Deviation 9.008
GW685698X 50 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=92, 94, 95, 106, 92, 97	4.70 Percentage	Standard Deviation 2.056
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=92, 94, 95, 106, 92, 97	5.20 Percentage	Standard Deviation 2.113
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=72, 80, 83, 94, 82, 79	4.60 Percentage	Standard Deviation 2.178
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=72, 80, 83, 94, 82, 79	0.35 Percentage	Standard Deviation 0.236
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79	60.86 Percentage	Standard Deviation 8.054
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=92, 94, 95, 106, 92, 97	56.34 Percentage	Standard Deviation 9.832
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=92, 94, 95, 106, 92, 97	0.32 Percentage	Standard Deviation 0.19
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=72, 80, 83, 94, 82, 79	30.39 Percentage	Standard Deviation 7.326
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=92, 94, 95, 106, 92, 97	33.69 Percentage	Standard Deviation 8.682
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=72, 80, 83, 94, 82, 79	3.77 Percentage	Standard Deviation 3.066
GW685698X 100 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=92, 94, 95, 106, 92, 97	4.40 Percentage	Standard Deviation 3.286
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=92, 94, 95, 106, 92, 97	4.78 Percentage	Standard Deviation 2.301
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=72, 80, 83, 94, 82, 79	3.96 Percentage	Standard Deviation 2.867
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=92, 94, 95, 106, 92, 97	34.32 Percentage	Standard Deviation 8.806
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=72, 80, 83, 94, 82, 79	31.97 Percentage	Standard Deviation 7.44
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=92, 94, 95, 106, 92, 97	0.33 Percentage	Standard Deviation 0.205
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=72, 80, 83, 94, 82, 79	4.50 Percentage	Standard Deviation 2.174
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79	59.20 Percentage	Standard Deviation 8.881
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=92, 94, 95, 106, 92, 97	55.80 Percentage	Standard Deviation 10.281
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=92, 94, 95, 106, 92, 97	4.75 Percentage	Standard Deviation 3.358
GW685698X 200 µg OD	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=72, 80, 83, 94, 82, 79	0.35 Percentage	Standard Deviation 0.22
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, W8, n=72, 80, 83, 94, 82, 79	32.22 Percentage	Standard Deviation 7.877
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79	59.19 Percentage	Standard Deviation 8.672
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils,W8, n=72, 80, 83, 94, 82, 79	0.34 Percentage	Standard Deviation 0.264
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, BL, n=92, 94, 95, 106, 92, 97	3.88 Percentage	Standard Deviation 3.073
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Lymphocytes, BL, n=92, 94, 95, 106, 92, 97	34.25 Percentage	Standard Deviation 8.514
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, BL, n=92, 94, 95, 106, 92, 97	4.92 Percentage	Standard Deviation 2.093
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Eosinophils, W8, n=72, 80, 83, 94, 82, 79	3.34 Percentage	Standard Deviation 2.364
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Monocytes, W8, n=72, 80, 83, 94, 82, 79	4.87 Percentage	Standard Deviation 2.38
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Basophils, BL, n=92, 94, 95, 106, 92, 97	0.33 Percentage	Standard Deviation 0.234
FP 100 µg BID	Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8	Total Neutrophils, BL, n=92, 94, 95, 106, 92, 97	56.60 Percentage	Standard Deviation 9.226

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=91, 91, 95, 106, 92, 95	271.68 10^9 cells per liter (GI/L)	Standard Deviation 62.861
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=72, 76, 83, 93, 81, 78	265.47 10^9 cells per liter (GI/L)	Standard Deviation 49.978
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=92, 94, 95, 106, 92, 97	7.82 10^9 cells per liter (GI/L)	Standard Deviation 2.018
Placebo	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=72, 79, 83, 94, 82, 79	7.56 10^9 cells per liter (GI/L)	Standard Deviation 1.679
GW685698X 25 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=92, 94, 95, 106, 92, 97	7.96 10^9 cells per liter (GI/L)	Standard Deviation 1.892
GW685698X 25 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=72, 76, 83, 93, 81, 78	262.07 10^9 cells per liter (GI/L)	Standard Deviation 45.837
GW685698X 25 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=91, 91, 95, 106, 92, 95	265.75 10^9 cells per liter (GI/L)	Standard Deviation 51.446
GW685698X 25 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=72, 79, 83, 94, 82, 79	8.26 10^9 cells per liter (GI/L)	Standard Deviation 2.169
GW685698X 50 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=72, 79, 83, 94, 82, 79	8.34 10^9 cells per liter (GI/L)	Standard Deviation 2.211
GW685698X 50 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=92, 94, 95, 106, 92, 97	8.01 10^9 cells per liter (GI/L)	Standard Deviation 2.095
GW685698X 50 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=72, 76, 83, 93, 81, 78	271.03 10^9 cells per liter (GI/L)	Standard Deviation 47.156
GW685698X 50 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=91, 91, 95, 106, 92, 95	279.38 10^9 cells per liter (GI/L)	Standard Deviation 57.658
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=91, 91, 95, 106, 92, 95	272.20 10^9 cells per liter (GI/L)	Standard Deviation 61.111
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=72, 79, 83, 94, 82, 79	7.94 10^9 cells per liter (GI/L)	Standard Deviation 2.046
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=72, 76, 83, 93, 81, 78	278.57 10^9 cells per liter (GI/L)	Standard Deviation 58.302
GW685698X 100 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=92, 94, 95, 106, 92, 97	7.62 10^9 cells per liter (GI/L)	Standard Deviation 1.878
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=92, 94, 95, 106, 92, 97	7.79 10^9 cells per liter (GI/L)	Standard Deviation 2.055
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=72, 79, 83, 94, 82, 79	7.94 10^9 cells per liter (GI/L)	Standard Deviation 1.769
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=72, 76, 83, 93, 81, 78	272.53 10^9 cells per liter (GI/L)	Standard Deviation 68.404
GW685698X 200 µg OD	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=91, 91, 95, 106, 92, 95	268.37 10^9 cells per liter (GI/L)	Standard Deviation 60.442
FP 100 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, W8, n=72, 76, 83, 93, 81, 78	274.46 10^9 cells per liter (GI/L)	Standard Deviation 61.819
FP 100 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, BL, n=92, 94, 95, 106, 92, 97	7.94 10^9 cells per liter (GI/L)	Standard Deviation 1.982
FP 100 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	WBC, W8, n=72, 79, 83, 94, 82, 79	8.00 10^9 cells per liter (GI/L)	Standard Deviation 2.292
FP 100 µg BID	Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8	Platelet count, BL, n=91, 91, 95, 106, 92, 95	281.26 10^9 cells per liter (GI/L)	Standard Deviation 66.492

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 (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	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, BL, n=92, 94, 95, 106, 92, 97	4.71 10^12 cells per liter (TI/L)	Standard Deviation 0.429
Placebo	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, W8, n=72, 79, 83, 94, 82, 79	4.65 10^12 cells per liter (TI/L)	Standard Deviation 0.41
GW685698X 25 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, BL, n=92, 94, 95, 106, 92, 97	4.65 10^12 cells per liter (TI/L)	Standard Deviation 0.438
GW685698X 25 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, W8, n=72, 79, 83, 94, 82, 79	4.61 10^12 cells per liter (TI/L)	Standard Deviation 0.445
GW685698X 50 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, BL, n=92, 94, 95, 106, 92, 97	4.68 10^12 cells per liter (TI/L)	Standard Deviation 0.425
GW685698X 50 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, W8, n=72, 79, 83, 94, 82, 79	4.63 10^12 cells per liter (TI/L)	Standard Deviation 0.435
GW685698X 100 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, BL, n=92, 94, 95, 106, 92, 97	4.71 10^12 cells per liter (TI/L)	Standard Deviation 0.46
GW685698X 100 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, W8, n=72, 79, 83, 94, 82, 79	4.67 10^12 cells per liter (TI/L)	Standard Deviation 0.45
GW685698X 200 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, BL, n=92, 94, 95, 106, 92, 97	4.68 10^12 cells per liter (TI/L)	Standard Deviation 0.422
GW685698X 200 µg OD	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, W8, n=72, 79, 83, 94, 82, 79	4.60 10^12 cells per liter (TI/L)	Standard Deviation 0.369
FP 100 µg BID	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, BL, n=92, 94, 95, 106, 92, 97	4.71 10^12 cells per liter (TI/L)	Standard Deviation 0.416
FP 100 µg BID	Red Blood Cells (RBC) Count at Baseline and Week 8	RBC, W8, n=72, 79, 83, 94, 82, 79	4.65 10^12 cells per liter (TI/L)	Standard Deviation 0.462

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	Week 8, n=71, 81, 82, 93, 82, 77	6.03 scores on a scale	Standard Deviation 0.422
Placebo	Urine pH at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	6.04 scores on a scale	Standard Deviation 0.487
Placebo	Urine pH at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	6.00 scores on a scale	Standard Deviation 0.707
GW685698X 25 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	6.01 scores on a scale	Standard Deviation 0.418
GW685698X 25 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	6.05 scores on a scale	Standard Deviation 0.418
GW685698X 25 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	6.00 scores on a scale	Standard Deviation 0
GW685698X 50 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	6.12 scores on a scale	Standard Deviation 0.462
GW685698X 50 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	6.06 scores on a scale	Standard Deviation 0.455
GW685698X 50 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	5.75 scores on a scale	Standard Deviation 0.354
GW685698X 100 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	6.06 scores on a scale	Standard Deviation 0.435
GW685698X 100 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	6.13 scores on a scale	Standard Deviation 0.488
GW685698X 100 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	6.83 scores on a scale	Standard Deviation 0.289
GW685698X 200 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	6.06 scores on a scale	Standard Deviation 0.523
GW685698X 200 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	6.05 scores on a scale	Standard Deviation 0.489
GW685698X 200 µg OD	Urine pH at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	7.50 scores on a scale	Standard Deviation 0
FP 100 µg BID	Urine pH at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	6.08 scores on a scale	Standard Deviation 0.415
FP 100 µg BID	Urine pH at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	5.86 scores on a scale	Standard Deviation 0.556
FP 100 µg BID	Urine pH at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	5.96 scores on a scale	Standard Deviation 0.342

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: 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	Week 8, n=71, 81, 82, 93, 82, 77	1.0238 ratio	Standard Deviation 0.00731
Placebo	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	1.0230 ratio	Standard Deviation 0.00707
Placebo	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	1.0265 ratio	Standard Deviation 0.00071
GW685698X 25 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	1.0227 ratio	Standard Deviation 0.00735
GW685698X 25 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	1.0240 ratio	Standard Deviation 0.0069
GW685698X 25 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	1.0121 ratio	Standard Deviation 0
GW685698X 50 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	1.0230 ratio	Standard Deviation 0.00714
GW685698X 50 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	1.0236 ratio	Standard Deviation 0.00682
GW685698X 50 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	1.0200 ratio	Standard Deviation 0.00141
GW685698X 100 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	1.0223 ratio	Standard Deviation 0.00738
GW685698X 100 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	1.0230 ratio	Standard Deviation 0.00687
GW685698X 100 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	1.0233 ratio	Standard Deviation 0.00987
GW685698X 200 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	1.0235 ratio	Standard Deviation 0.00727
GW685698X 200 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	1.0242 ratio	Standard Deviation 0.0062
GW685698X 200 µg OD	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	1.0190 ratio	Standard Deviation 0
FP 100 µg BID	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Baseline, n=92, 94, 95, 106, 93, 96	1.0227 ratio	Standard Deviation 0.0076
FP 100 µg BID	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	EW, n=2, 1, 2, 3, 1, 7	1.0240 ratio	Standard Deviation 0.00653
FP 100 µg BID	Urine Specific Gravity at Baseline and Week 8/Early Withdrawal	Week 8, n=71, 81, 82, 93, 82, 77	1.0217 ratio	Standard Deviation 0.00751

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal 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 Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid 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