An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02294734
• Collaborator: (none)
• Enrollment: 126
• Locations: 17
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety, tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks including screening, treatment period and a follow up visit. Subjects will receive once daily study treatment administration starting on Day 1. Study is planned to recruit approximately 120 subjects such that approximately 100 subjects complete the study.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: GSK2269557; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of GSK2269557 Administered in Addition to Standard of Care in Adult Subjects Diagnosed With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Actual Study Start Date: Mar 31, 2015
• Actual Primary Completion Date: Feb 19, 2016
• Actual Study Completion Date: Apr 25, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK2269557 repeat dose Participants will receive 2 inhalation of GSK2269557 dry powder once daily via DISKUS™ 'device' (DISKUS is a trademark of the GSK group of companies)	Drug: GSK2269557; Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily
Placebo Comparator: Matching placebo repeat dose Participants will receive 2 inhalation matching placebo dry powder once daily via DISKUS 'device'	Drug: Placebo; Dry powder for inhalation via DISKUS 'device'

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28 [Baseline, Day 12 and Day 28]

   siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

Secondary Outcome Measures

1. Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28 [Baseline, Day 12 and Day 28]

   iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

2. Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28 [Baseline, Day 12 and Day 28]

   iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

3. Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28 [Baseline, Day 12 and Day 28]

   siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

4. Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28 [Baseline, Day 12 and Day 28]

   Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 & Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).

5. Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment [Baseline, Day 12 and Day 28]

   Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

6. Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment [Baseline, Day 12 and Day 28]

   Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

7. Number of Participants With Adverse Events (AE) [From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)]

   An 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. Adverse events were collected from the start of study treatment until the follow-up contact.

8. Number of Participants With Abnormal Hematology Parameters [Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)]

   Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

9. Number of Participants With Abnormal Clinical Chemistry Parameters [Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)]

   Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

10. Number of Participants With Abnormal Vital Signs [Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)]

    Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

11. Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) [Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)]

    12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

12. Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose [Pre-dose, 5 min, 3 hrs and 24 hrs]

    Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.

13. Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment [Pre-dose Day 12, Day 28, Day 56, and Day 84]

    Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

14. Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily [Baseline, Day 28, and Day 84]

    FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

15. Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily [Baseline, Day 28, and Day 84]

    PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

16. Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment [Baseline, Day 28 and Day 84]

    DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

17. Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment [Baseline, Day 28 and Day 84]

    TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.

18. Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment [Baseline, Day 28 and Day 84]

    Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.

19. Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment [Baseline, Day 28 and Day 84]

    Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

20. Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment [Baseline, Day 28 and Day 84]

    sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

21. Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment [Baseline, Day 28 and Day 84]

    Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.

22. Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84 [Baseline, Day 28 and Day 84]

    The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

23. Number of Participants With Treatment Failures [13 weeks]

    Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Between 40 and 80 years of age inclusive, at the time of signing the informed consent

• The subject has a confirmed and established diagnosis of COPD, as defined by the global initiative for chronic Obstructive Lung Disease (GOLD) guidelines for at least 6 months prior to entry.

• The subject has a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.7 and FEV1 <= 80 % of predicted (Predictions should be according to the European Community of Coal and Steel [ECCS] equations), documented in the last 5 years.

• Disease severity: Acute exacerbation of COPD requiring an escalation in therapy to include corticosteroid and antibiotics. Acute exacerbation to be confirmed by an experienced physician and represent a recent change in at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms: subjective increase in dyspnea, increase in sputum volume, and change in sputum colour. Minor symptoms: cough, wheeze and sore throat.

• The subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (pack years = [cigarettes per day smoked/20 x number of years smoked])

• Body weight >= 45 kilogram (kg) and body mass index (BMI) within the range 18 - 32 kg/metered squared (m^2) (inclusive).

• Male

• Female subject : is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies:

Non-reproductive potential defined as: Pre-menopausal females with one of the following:

documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy and documented bilateral oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until completion of the follow-up visit.

GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in

Females of Reproductive Potential (FRP):

Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label.

Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label.

Oral Contraceptive, either combined or progestogen alone. Injectable progestogen. Contraceptive vaginal ring. Percutaneous contraceptive patches. Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.

Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository).

• Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until after the completion of the follow up visit.

Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label. Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label. Oral Contraceptive, either combined or progestogen alone or injectable progestogen. Contraceptive vaginal ring. Percutaneous contraceptive patches.

These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the study protocol.

Exclusion Criteria:

• To avoid recruitment of subjects with a severe COPD exacerbation, the presence of any one of the following severity criteria will render the subject ineligible for inclusion in the study:

Need for invasive mechanical ventilation (short term (< 48hour) Non-invasive Ventilation (NIV) or Continuous Positive Airway Pressure [CPAP] is acceptable).

Haemodynamic instability or clinically significant heart failure. Confusion.

• Subjects who have a history or current medical conditions or diseases that are not well controlled and, which as judged by the Investigator, may affect subject safety or influence the outcome of the study. (Note: Patients with adequately treated and well controlled concurrent medical conditions [e.g. hypertension or non-insulin dependent diabetes mellitus] are permitted to be entered into the study).

• Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, pulmonary fibrosis, asthma or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results.

• Alanine aminotransferase >2x upper limit of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

• A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the exclusion criteria, outside of the reference range for the population being studied may be included if the Investigator [in consultation with the GSK Medical Monitor if required] documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• ECG indicative of an acute cardiac event (e.g. Myocardial Infarction) or demonstrating a clinically significant arrhythmia requiring treatment.

• QTcF > 450 millisecond (msec) or QTcF > 480 msec in subjects with Bundle Branch Block, based on single QTcF value.

• Subjects who have undergone lung volume reduction surgery.

• Subject is currently on chronic treatment with macrolides; long term oxygen therapy (> 15 hours/day).

• The subject has been on chronic treatment with anti-Tumour Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), or any other immunosuppressive therapy within 60 days prior to dosing.

• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >28 units for males or >21 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint ( equivalent to 240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

• History of sensitivity to any of the study medications, or components thereof (such as lactose) or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

• A known (historical) positive test for human immune virus (HIV) antibody.

• Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. NOTE: Because of the short window for screening, treatment with GSK2269557 may start before receiving the result of the hepatitis tests. If subsequently the test is found to be positive, the subject may be withdrawn, as judged by the Principal Investigator in consultation with the Medical Monitor.

• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.

• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

• Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Edegem		Belgium	2650
2	GSK Investigational Site	Erpent		Belgium	5101
3	GSK Investigational Site	Aalborg		Denmark	DK-9100
4	GSK Investigational Site	Hvidovre		Denmark	2650
5	GSK Investigational Site	Kobenhavn		Denmark	DK-2400
6	GSK Investigational Site	Odense		Denmark	5000 Odense C
7	GSK Investigational Site	Almelo		Netherlands	7609 PP
8	GSK Investigational Site	Eindhoven		Netherlands	5623 EJ
9	GSK Investigational Site	Zutphen		Netherlands	7207 AE
10	GSK Investigational Site	Bucharest		Romania	050159
11	GSK Investigational Site	Timisoara		Romania	300310
12	GSK Investigational Site	Ekaterinburg		Russian Federation	620109
13	GSK Investigational Site	Kemerovo		Russian Federation	650002
14	GSK Investigational Site	Moscow		Russian Federation	105 077
15	GSK Investigational Site	Saint Petersburg		Russian Federation	194291
16	GSK Investigational Site	Vladimir		Russian Federation	600023
17	GSK Investigational Site	Yaroslavl		Russian Federation	150003

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cahn A, Hamblin JN, Robertson J, Begg M, Jarvis E, Wilson R, Dear G, Leemereise C, Cui Y, Mizuma M, Montembault M, Van Holsbeke C, Vos W, De Backer W, De Backer J, Hessel EM. An Inhaled PI3Kδ Inhibitor Improves Recovery in Acutely Exacerbating COPD Patients: A Randomized Trial. Int J Chron Obstruct Pulmon Dis. 2021 Jun 3;16:1607-1619. doi: 10.2147/COPD.S309129. eCollection 2021.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02294734
• Other Study ID Numbers: 116678; 2014-001972-70
• First Posted: Nov 19, 2014
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: functional respiratory capacity; High-resolution computed tomography; GSK2269557; acute exacerbation of COPD; lung capacity
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Nemiralisib

Study Results

Participant Flow

Recruitment Details	The study consisted of a screening visit, a 12-week treatment period, and a 1-2 week post-treatment follow-up. The total duration of the study was 13-14 weeks including the screening visit.
Pre-assignment Detail	Approximately 120 participants with an acute exacerbation of chronic obstructive pulmonary disease (COPD) were randomized (1:1) to GSK 2269557 1000 micrograms (µg) and placebo such that approximately 100 participants complete the study. Participants were also stratified by whether they were willing and able to provide sputum samples at screening.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Period Title: Overall Study
STARTED	63	63
COMPLETED	49	55
NOT COMPLETED	14	8

Baseline Characteristics

Arm/Group Title	Placebo	GSK2269557 1000 mcg	Total
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Total of all reporting groups
Overall Participants	63	63	126
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.9 (7.88)	65.6 (7.14)	65.2 (7.50)
Sex: Female, Male (Count of Participants)
Female	17 27%	17 27%	34 27%
Male	46 73%	46 73%	92 73%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native	0 0%	1 1.6%	1 0.8%
White - White/Caucasian/European Heritage	63 100%	62 98.4%	125 99.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
Description	siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

Intention to Treat (ITT) Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC; Longitudinal; Lobes; RUL; D12 , n =54, 57	1.033	1.052
FRC; Longitudinal; Lobes; RUL; D28 , n =56, 56	0.983	1.075
FRC; Longitudinal; Lobes; LUL; D12 , n=56, 59	0.975	1.000
FRC; Longitudinal; Lobes; LUL; D28 , n =56, 58	0.893	1.090
FRC; Longitudinal; Lobes; RML; D12 , n =52, 58	0.956	0.871
FRC; Longitudinal; Lobes; RML; D28 , n=53, 57	0.853	1.006
FRC; Longitudinal; Lobes; RLL; D12 , n =54, 59	0.908	1.115
FRC; Longitudinal; Lobes; RLL; D28 , n =55, 58	0.871	1.167
FRC; Longitudinal; Lobes; LLL; D12 , n =53, 58	1.051	1.087
FRC; Longitudinal; Lobes; LLL; D28 ,n =54, 58	1.000	1.199
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 57	1.049	1.002
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 56	0.999	0.993
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 55	0.931	0.995
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59	0.979	1.012
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58	0.952	1.018
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57	0.973	1.014
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =52, 58	0.924	0.977
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 57	0.927	0.967
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 56	0.927	1.023
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59	0.987	1.000
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58	0.972	1.014
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57	0.920	1.015
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58	1.031	1.050
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58	1.034	1.064
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56	0.978	1.055
FRC; Longitudinal;Region; Upper; D12 , n =56, 59	0.952	1.004
FRC; Longitudinal; Region; Upper; D28 , n =56, 58	0.918	1.066
FRC; Longitudinal; Region; Lower; D12 , n=54, 59	0.989	1.065
FRC; Longitudinal; Region; Lower; D28 , n =55, 58	0.952	1.150
FRC; Longitudinal; Region;Central; D12 , n =56, 59	0.969	1.021
FRC; Longitudinal;Region; Central; D28 , n=56, 58	0.992	1.002
FRC; Longitudinal; Region; Distal; D12 , n =56, 59	0.963	1.027
FRC; Longitudinal; Region; Distal D28 , n =56, 58	0.939	1.098
FRC; Longitudinal; Region;Total; D12, n =56, 59	0.970	1.018
FRC; Longitudinal; Region; Total; D28 ,n =56, 58	0.989	1.009
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59	0.989	1.001
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58	0.962	1.007
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57	0.967	1.011
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59	1.019	1.028
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58	1.002	1.039
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57	0.953	1.008
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59	0.988	1.022
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58	1.002	0.999
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57	0.998	0.977
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59	0.998	1.009
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58	0.984	1.021
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57	0.963	1.019
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59	0.989	1.019
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58	1.002	1.000
Trimmed;Region;Total; D12D28 , n =53, 57	0.995	0.982
TLC; Longitudinal; Lobes; RUL; D12 , n =58, 57	1.048	0.976
TLC; Longitudinal; Lobes; RUL; D28 , n =56, 57	1.045	0.979
TLC; Longitudinal; Lobes; LUL; D12 , n=58, 59	1.043	1.007
TLC; Longitudinal; Lobes; LUL; D28 , n =56, 59	1.078	1.027
TLC; Longitudinal; Lobes; RML; D12 , n =57, 58	1.087	0.894
TLC; Longitudinal; Lobes; RML; D28 , n=56, 58	1.084	0.903
TLC; Longitudinal; Lobes; RLL; D12 , n =58, 59	1.038	0.906
TLC; Longitudinal; Lobes; RLL; D28 , n =56, 59	1.014	0.948
TLC; Longitudinal; Lobes; LLL; D12 , n =57, 59	1.074	0.934
TLC; Longitudinal; Lobes; LLL; D28 ,n =55, 59	1.075	0.993
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =58, 57	1.040	0.988
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 57	1.020	0.981
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =55, 56	0.971	1.002
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =58, 59	1.022	1.001
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 59	1.035	0.991
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =55, 58	1.007	1.002
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =57, 58	1.029	0.934
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 58	1.020	0.932
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =55, 57	0.980	1.008
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =58, 59	1.022	0.932
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 59	0.984	0.944
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =55, 58	0.962	1.027
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =57, 59	1.024	0.967
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 59	1.025	0.972
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n =54, 58	0.984	1.017
TLC; Longitudinal;Region; Upper; D12 , n =58, 59	1.031	0.983
TLC; Longitudinal; Region; Upper; D28 , n =56, 59	1.046	0.995
TLC; Longitudinal; Region; Lower; D12 , n=58, 59	1.051	0.924
TLC; Longitudinal; Region; Lower; D28 , n =56, 59	1.037	0.974
TLC; Longitudinal; Region;Central; D12 , n =58, 59	1.001	0.991
TLC; Longitudinal;Region; Central; D28 , n=56, 59	1.006	0.992
TLC; Longitudinal; Region; Distal; D12 , n =58, 59	1.043	0.949
TLC; Longitudinal; Region; Distal D28 , n =56, 59	1.039	0.982
TLC; Longitudinal; Region;Total; D12, n =58, 59	1.009	0.982
TLC; Longitudinal; Region; Total; D28 ,n =56, 59	1.005	0.988
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =58, 59	1.028	0.992
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 59	1.021	0.984
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =55, 58	0.985	1.003
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =58, 59	1.021	0.954
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 59	0.996	0.960
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =55, 58	0.972	1.018
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =58, 59	1.000	0.997
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 59	1.005	0.995
TLC;Scan Trimmed;Region Central; D12D28 ,n =55, 58	1.004	0.998
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =58, 59	1.025	0.972
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 59	1.008	0.972
TLC;Scan Trimmed;Region;Distal; D12D28 , n =55, 58	0.978	1.011
TLC;Scan Trimmed; Region;Total; SCRD12 , n =58, 59	1.005	0.991
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 59	1.004	0.989
TLC; Scan Trimmed;Region;Total; D12D28 , n =55, 58	0.997	1.000

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	60.66
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.21
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	74.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.48
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95%; 1.06 to 1.58
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	13.98
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.92
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.28
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.62
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	80.24
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.79
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.66
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	51.27
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	90.66
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	54.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.45
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.09
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	62.95
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.86
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.16
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	48.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.51
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.59
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	61.27
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.63
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.02
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	53.24
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	70.84
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	74.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	65.43
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	91.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	76.81
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	67.01
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.91
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.47
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	72.17
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	74.38
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	53.85
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.02
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	92.27
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	54.65
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	87.93
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	77.57
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	77.07
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	78.42
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	44.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	52.79
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.51
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	93.16
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	73.70
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	81.04
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	52.58
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	15.85
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	48.69
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	52.25
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	66.48
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.12
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	16.95
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	50.40
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	7.44
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	56.35
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 61

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	4.03
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 62

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	24.79
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 63

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	77.08
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 64

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	23.07
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 65

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	18.58
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 66

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	44.94
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 67

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	2.21
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 68

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	6.09
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 69

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	66.60
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 70

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	3.23
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 71

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	20.83
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 72

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	87.60
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 73

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	7.90
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 74

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	23.39
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 75

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	76.16
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 76

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	22.54
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 77

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	58.17
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 78

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	6.22
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 79

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	55.85
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 80

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	25.44
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 81

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	18.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 82

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	8.12
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 83

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	57.39
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 84

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	10.00
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 85

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	29.88
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 86

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	12.63
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 87

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	32.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 88

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	69.92
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 89

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	6.10
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 90

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	33.63
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 91

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	86.07
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 92

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	41.38
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 93

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	24.88
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 94

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	29.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 95

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	7.13
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 96

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	32.91
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 97

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	81.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 98

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	21.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 99

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	24.49
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 100

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	55.52
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

2. Secondary Outcome

Title	Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
Description	iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

ITT Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC; Longitudinal; Lobes; RUL; D12 , n =54, 59	1.020	1.058
FRC; Longitudinal; Lobes; RUL; D28 , n =56, 58	0.960	1.121
FRC; Longitudinal; Lobes; LUL; D12 , n=56, 59	0.951	0.999
FRC; Longitudinal; Lobes; LUL; D28 , n =56, 58	0.876	1.108
FRC; Longitudinal; Lobes; RML; D12 , n =53, 59	0.905	0.869
FRC; Longitudinal; Lobes; RML; D28 , n=53, 58	0.835	1.013
FRC; Longitudinal; Lobes; RLL; D12 , n =54, 59	0.889	1.119
FRC; Longitudinal; Lobes; RLL; D28 , n =55, 58	0.850	1.177
FRC; Longitudinal; Lobes; LLL; D12 , n =53, 58	1.017	1.067
FRC; Longitudinal; Lobes; LLL; D28 ,n =54, 58	0.980	1.187
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 59	1.035	1.006
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58	0.976	1.027
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 57	0.927	1.018
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59	0.954	1.010
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58	0.933	1.035
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57	0.981	1.029
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =53, 59	0.905	0.970
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 58	0.907	0.972
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 57	0.927	1.031
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59	0.968	1.004
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58	0.948	1.022
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57	0.916	1.018
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58	0.997	1.031
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58	1.013	1.054
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56	0.989	1.061
FRC; Longitudinal;Region; Upper; D12 , n =56, 59	0.933	1.000
FRC; Longitudinal; Region; Upper; D28 , n =56, 58	0.898	1.079
FRC; Longitudinal; Region; Lower; D12 , n=54, 59	0.965	1.058
FRC; Longitudinal; Region; Lower; D28 , n =55, 58	0.931	1.151
FRC; Longitudinal; Region;Central; D12 , n =56, 59	0.945	1.016
FRC; Longitudinal;Region; Cetral; D28 , n=56, 58	0.968	1.010
FRC; Longitudinal; Region; Distal; D12 , n =56, 59	0.939	1.022
FRC; Longitudinal; Region; Distal D28 , n =56, 58	0.917	1.107
FRC; Longitudinal; Region;Total; D12 n =56, 59	0.946	1.012
FRC; Longitudinal; Region; Total; D28 ,n =56, 58	0.966	1.017
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59	0.969	0.997
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58	0.941	1.019
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57	0.968	1.025
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59	0.994	1.022
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58	0.980	1.040
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57	0.954	1.013
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59	0.964	1.016
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58	0.978	1.007
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57	1.000	0.988
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59	0.974	1.003
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58	0.960	1.030
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57	0.965	1.030
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59	0.965	1.014
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58	0.978	1.008
FRC; Scan Trimmed;Region;Total; D12D28 , n =53, 57	0.998	0.993
TLC; Longitudinal; Lobes; RUL; D12 , n =58, 59	1.057	0.982
TLC; Longitudinal; Lobes; RUL; D28 , n =56, 59	1.050	0.989
TLC; Longitudinal; Lobes; LUL; D12 , n=58, 59	1.045	1.005
TLC; Longitudinal; Lobes; LUL; D28 , n =56, 59	1.082	1.025
TLC; Longitudinal; Lobes; RML; D12 , n =58, 59	1.045	0.887
TLC; Longitudinal; Lobes; RML; D28 , n=56, 59	1.076	0.906
TLC; Longitudinal; Lobes; RLL; D12 , n =58, 59	1.049	0.910
TLC; Longitudinal; Lobes; RLL; D28 , n =56, 59	1.014	0.956
TLC; Longitudinal; Lobes; LLL; D12, n =57, 59	1.082	0.924
TLC; Longitudinal; Lobes; LLL; D28 ,n =55, 59	1.077	0.989
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =58, 59	1.049	0.994
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 59	1.025	0.987
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =55, 58	0.966	1.002
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =58, 59	1.024	0.999
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 59	1.039	0.989
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =55, 58	1.008	1.002
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =58, 59	1.017	0.926
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 59	1.013	0.935
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =55, 58	0.974	1.021
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =58, 59	1.032	0.936
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 59	0.983	0.952
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =55, 58	0.953	1.033
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =57, 59	1.032	0.956
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 59	1.027	0.968
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n =54, 58	0.976	1.025
TLC; Longitudinal;Region; Upper; D12 , n =58, 59	1.037	0.981
TLC; Longitudinal; Region; Upper; D28 , n =56, 59	1.049	0.994
TLC; Longitudinal; Region; Lower; D12 , n=58, 59	1.061	0.921
TLC; Longitudinal; Region; Lower; D28 , n =56, 59	1.037	0.977
TLC; Longitudinal; Region;Central; D12 , n =58, 59	1.006	0.988
TLC; Longitudinal;Region; Cetral; D28 , n=56, 59	1.007	0.993
TLC; Longitudinal; Region; Distal; D12 , n =58, 59	1.048	0.947
TLC; Longitudinal; Region; Distal D28 , n =56, 59	1.041	0.983
TLC; Longitudinal; Region;Total; D12, n =58, 59	1.014	0.979
TLC; Longitudinal; Region; Total; D28 ,n =56, 59	1.007	0.989
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =58, 59	1.033	0.989
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 59	1.025	0.983
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =55, 58	0.983	1.006
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =58, 59	1.030	0.951
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 59	0.997	0.963
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =55, 58	0.964	1.025
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =58, 59	1.005	0.994
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 59	1.007	0.995
TLC;Scan Trimmed;Region Central; D12D28 ,n =55, 58	1.000	1.003
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =58, 59	1.030	0.969
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 59	1.010	0.973
TLC;Scan Trimmed;Region;Distal; D12D28 , n =55, 58	0.975	1.016
TLC;Scan Trimmed; Region;Total; SCRD12 , n =58, 59	1.010	0.989
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 59	1.006	0.990
TLC; Scan Trimmed;Region;Total; D12D28 , n =55, 58	0.993	1.005

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	59.55
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.01
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	82.27
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.22
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 1.06 to 1.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	46.24
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.30
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	92.60
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.01
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; 1.05 to 1.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	58.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	86.82
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	67.37
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.35
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.86
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	86.18
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	91.94
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	55.32
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.17
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.57
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	79.13
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.54
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 1.05 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	71.94
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	85.30
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	82.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	72.55
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.44
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	78.24
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	91.11
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	89.30
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	74.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.25
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	87.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	91.54
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	68.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.19
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.07
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.74
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.83
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	79.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.27
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	47.62
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	71.55
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.09
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Bayesian repeated measures model
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	93.68
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.58
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	56.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	13.08
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	52.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	60.75
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.23
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.92 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	28.14
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	38.43
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	25.21
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	81.73
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 61

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	4.03
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 62

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	30.03
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 63

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	80.34
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 64

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	25.65
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 65

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	24.36
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 66

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	48.45
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 67

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	1.95
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.81 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 68

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	14.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 69

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	80.61
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 70

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	3.30
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 71

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	42.22
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 72

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.24
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 73

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	6.38
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 74

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	28.82
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 75

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	87.39
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 76

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	23.27
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 77

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	57.82
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 78

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 79

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	70.73
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 80

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	25.61
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 81

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	44.10
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 82

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	10.14
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 83

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	62.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 84

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	11.82
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 85

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	51.44
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 86

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.54
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.88 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 87

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	30.03
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 88

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	73.03
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 89

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	4.64
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model.
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 90

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	42.13
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 91

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	93.33
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 92

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	27.33
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 93

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	34.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 94

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	58.42
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 95

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	5.93
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 96

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	35.88
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 97

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	86.41
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 98

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	13.52
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 99

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	32.84
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 100

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	78.09
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

3. Secondary Outcome

Title	Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
Description	iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

ITT Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 59	0.908	0.948
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58	0.849	0.958
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 57	1.039	0.898
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59	0.982	0.946
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58	0.937	0.820
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57	0.842	0.934
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =53, 59	1.022	0.998
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 58	1.378	0.886
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 57	1.027	1.198
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59	1.100	1.043
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58	1.504	1.044
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57	1.289	1.126
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58	0.781	0.738
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58	0.949	0.818
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56	1.051	1.012
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59	0.934	0.960
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58	0.940	0.887
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57	0.869	1.127
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59	0.845	0.821
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58	1.215	0.868
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57	1.113	1.193
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59	1.104	0.933
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58	1.079	0.950
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57	1.033	1.010
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59	0.800	0.859
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58	0.993	0.873
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57	0.887	1.220
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59	1.006	0.919
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58	1.036	0.922
FRC; Scan Trimmed;Region;Total; D12D28 , n =53, 57	1.000	1.066
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =56, 59	0.843	0.978
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58	0.929	1.019
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =53, 57	1.152	0.901
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59	0.879	0.979
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58	0.922	0.886
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57	1.025	0.894
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =57, 58	1.076	1.349
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 59	0.989	1.220
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =56, 58	1.102	0.988
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =56, 59	0.848	1.143
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 58	0.965	1.122
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =53, 57	1.208	0.927
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =55, 59	0.813	1.139
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 58	0.958	0.987
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n=52, 57	1.313	0.829
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59	0.913	1.103
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58	0.958	0.957
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57	1.067	0.885
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =56, 59	0.850	1.116
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 58	0.953	1.056
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =53, 57	1.269	0.862
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59	0.960	1.007
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58	0.976	1.000
TLC;Scan Trimmed;Region Central; D12D28 ,n =53, 57	1.039	0.981
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59	0.889	1.116
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58	0.945	0.976
TLC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57	1.189	0.838
TLC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59	0.891	1.061
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58	0.956	0.989
TLC; Scan Trimmed;Region;Total; D12D28 , n =53, 57	1.133	0.904

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	60.07
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	51.75
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	65.66
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	81.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	89.98
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.51 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	43.88
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	36.10
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.74
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.47 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	50.74
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	72.81
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.51 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.41
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	81.07
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	69.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	73.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.82
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	54.22
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	66.46
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	21.45
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.71
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	69.91
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	44.05
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.58
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.93
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.11
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	85.41
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	54.73
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	72.31
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	15.05
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.75
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	84.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	92.24
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.42
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.05
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	66.40
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	97.39
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	16.02
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.69
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	90.22
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.64
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.62
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	20.44
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	55.06
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	5.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.36
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.97
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	28.82
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	93.00
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	1.64
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.42
	Confidence Interval	(2-Sided) 95%; 1.03 to 1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	50.71
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.38
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.52
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.51 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	3.10
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.39
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	93.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.68 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	3.79
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	36.75
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.32
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.56 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	18.91
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	47.35
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	78.00
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	2.65
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.67
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	58.48
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.64
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.61 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	1.90
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.03
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.19
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

4. Secondary Outcome

Title	Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
Description	siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

ITT Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 57	0.896	0.908
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 56	0.829	1.013
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 55	1.035	0.926
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59	0.957	0.944
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58	0.919	0.834
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57	0.849	0.948
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =52, 58	1.009	1.013
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 57	1.349	0.904
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 56	1.028	1.213
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59	1.078	1.046
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58	1.468	1.053
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57	1.284	1.130
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58	0.755	0.725
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58	0.930	0.811
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56	1.063	1.017
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59	0.915	0.956
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58	0.919	0.898
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57	0.870	1.142
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59	0.825	0.816
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58	1.188	0.869
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57	1.114	1.200
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59	1.077	0.928
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58	1.053	0.957
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57	1.035	1.022
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59	0.781	0.854
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58	0.969	0.880
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57	0.890	1.234
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59	0.982	0.914
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58	1.012	0.929
FRC; Scan Trimmed;Region;Total; D12D28 , n =53, 57	1.003	1.078
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =56, 59	0.848	0.989
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58	0.934	1.043
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =53, 57	1.142	0.903
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59	0.880	0.977
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58	0.926	0.885
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57	1.023	0.896
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =57, 58	1.073	1.343
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 59	0.981	1.238
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =56, 58	1.093	1.010
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =56, 59	0.854	1.149
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 58	0.964	1.134
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =53, 57	1.192	0.935
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =55, 59	0.820	1.126
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 58	0.960	0.985
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n=52, 57	1.302	0.839
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59	0.917	1.100
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58	0.961	0.957
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57	1.060	0.888
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =56, 59	0.856	1.112
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 58	0.954	1.061
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =53, 57	1.256	0.871
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59	0.963	1.004
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58	0.977	1.002
TLC;Scan Trimmed;Region Central; D12D28 ,n =53, 57	1.032	0.988
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59	0.892	1.112
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58	0.946	0.978
TLC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57	1.181	0.844
TLC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59	0.895	1.058
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58	0.958	0.991
TLC; Scan Trimmed;Region;Total; D12D28 , n =53, 57	1.125	0.911

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	67.19
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	44.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	59.90
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	70.12
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	83.98
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	34.93
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	32.45
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	95.35
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.46 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	50.10
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	59.37
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	87.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	70.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.71
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.51 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	65.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	71.95
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.60 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	48.28
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	61.06
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	18.05
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	61.12
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.53 to 1.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	64.40
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	38.12
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.66
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	91.00
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	94.52
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	82.11
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	48.10
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	65.66
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.64 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	11.46
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.80
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	77.20
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	87.35
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	56.53
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures random effect
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	7.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	55.09
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	96.49
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	14.54
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.90 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	66.85
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	85.77
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	8.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	14.80
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.75
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	45.69
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	2.94
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.42
	Confidence Interval	(2-Sided) 95%; 0.99 to 2.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	13.92
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.73
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	86.40
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.46
	Confidence Interval	(2-Sided) 95%; 1.06 to 2.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	41.25
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.20
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.52 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	3.49
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	73.09
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	92.41
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	2.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.89
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	23.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.59 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	14.50
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	30.26
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	62.84
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	2.06
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95%; 1.01 to 1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	49.97
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	99.43
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	1.17
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	49.78
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	98.66
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.73 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

5. Secondary Outcome

Title	Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
Description	Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 & Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

ITT Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC Lobes; RUL; Day 12, n =56, 57	0.983	0.995
FRC Lobes; RUL Day 28, n =56, 56	0.977	1.017
FRC Lobes; LUL Day 12, n =56, 59	0.974	0.998
FRC Lobes;LUL Day 28, n =56, 58	0.980	1.017
FRC Lobes; RML Day 12, n =55, 58	0.981	0.992
FRC Lobes; RML Day 28, n =56, 57	0.972	0.996
FRC Lobes; RLL Day 12, n =56, 59	0.977	1.004
FRC Lobes; RLL Day 28, n =56, 58	0.972	1.009
FRC Lobes; LLL Day 12, n =55, 59	0.968	0.983
FRC Lobes; LLL Day 28, n =55, 58	0.979	0.991
FRC Region; Upper Day 12, n =56, 59	0.980	0.996
FRC Region; Upper Day 28, n =56, 58	0.978	1.013
FRC Region; Lower Day 12, n =56, 59	0.975	0.994
FRC Region; Lower Day 28, n =56, 58	0.975	1.001
FRC Region; Total Day 12, n =56, 59	0.975	0.994
FRC Region; Total Day 28, n =56, 58	0.976	1.008
TLC Lobes; RUL; Day 12, n =58, 57	1.009	0.999
TLC Lobes; RUL Day 28, n =56, 57	1.005	0.999
TLC Lobes; LUL Day 12, n =58, 59	1.002	0.998
TLC Lobes;LUL Day 28, n =56, 59	1.004	0.998
TLC Lobes; RML Day 12, n =57, 58	0.998	0.988
TLC Lobes; RML Day 28, n =56, 58	0.992	0.996
TLC Lobes; RLL Day 12, n =58, 59	1.010	1.005
TLC Lobes; RLL Day 28, n =56, 59	1.000	1.009
TLC Lobes; LLL Day 12, n =57, 59	1.008	0.989
TLC Lobes; LLL Day 28, n =55, 59	1.002	0.996
TLC Upper Day 12, n =58, 59	1.005	0.997
TLC UpperDay 28, n =56, 59	1.004	0.999
TLC Lower Day 12, n =58, 59	1.009	0.997
TLC Lower Day 28, n =56, 59	1.000	1.003
TLC Total Day 12, n =58, 59	1.005	0.997
TLC Total Day 28, n =56, 59	1.002	1.001

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	32.51
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	6.21
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	15.91
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	6.73
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	27.65
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	12.19
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	11.62
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	7.66
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	28.88
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	28.28
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	27.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	9.83
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	21.87
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	18.58
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	22.28
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	10.86
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	84.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.78
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	69.42
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	62.63
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	72.55
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	36.28
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	47.44
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	22.99
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	85.95
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.94 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	60.20
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	81.34
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	63.04
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	69.67
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.96 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	39.81
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	73.01
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	48.97
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

6. Secondary Outcome

Title	Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
Description	Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

ITT Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC Length Day 12, n=56, 59	-1.886 (7.6043)	0.517 (6.0882)
FRC Length Day 28, n=56, 58	-1.434 (6.7887)	0.485 (6.6552)
FRC Diameter Day 12, n=56, 59	-0.247 (1.8777)	0.059 (1.1657)
FRC Diameter Day 28, n=56, 58	-0.261 (1.8672)	-0.047 (1.1522)
TLC Length Day 12, n=58, 59	0.295 (4.0608)	-0.663 (3.8027)
TLC Length Day 28, n=56, 59	0.168 (4.5501)	-0.495 (3.7295)
TLC Diameter Day 12, n=58, 59	-0.067 (1.0127)	-0.056 (0.5098)
TLC Diameter Day 28, n=56, 59	-0.046 (1.0240)	-0.082 (0.5579)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	2.89
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 1.00 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	8.49
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	86.21
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	75.20
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	84.29
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	71.08
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	34.93
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	25.05
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

7. Secondary Outcome

Title	Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment
Description	Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 12 and Day 28

Outcome Measure Data

Analysis Population Description

ITT Population excluding the subject with a pacemaker.

Arm/Group Title	Placebo	GSK2269557 1000 µg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 µg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62	63
FRC Length/Diameter Day 12, n=56	-0.030 (0.7717)	0.000 (0.5620)
FRC Length/Diameter Day 28, n=56	-0.017 (0.7469)	0.059 (0.5169)
TLC Length/Diameter Day 12, n=5	0.024 (0.3602)	-0.023 (0.2913)
TLC Length/Diameter Day 28, n=5	0.004 (0.3715)	-0.006 (0.2783)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	28.51
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	32.15
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	66.51
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.97 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	45.28
	Comments	The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Posterior Median Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.

8. Secondary Outcome

Title	Number of Participants With Adverse Events (AE)
Description	An 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. Adverse events were collected from the start of study treatment until the follow-up contact.
Time Frame	From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)

Outcome Measure Data

Analysis Population Description

All Subjects Population: all randomized participants who received at least one dose of study treatment.

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Number [Participants]	41 65.1%	49 77.8%

9. Secondary Outcome

Title	Number of Participants With Abnormal Hematology Parameters
Description	Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)

Outcome Measure Data

Analysis Population Description

All Subjects Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
High HCT Screening/Day 1, n=63, 62	4 6.3%	1 1.6%
High HCT Day 12, n=60, 58	1 1.6%	1 1.6%
High HCT Day 28, n=57, 58	1 1.6%	1 1.6%
High HCT Day 56, n=55, 52	1 1.6%	0 0%
High HCT Day 84, n=49, 53	2 3.2%	1 1.6%
High HCT Follow-up/Early Withdraw, n=54, 53	4 6.3%	0 0%
High HB Screening/ Day 1, n=63, 63	0 0%	1 1.6%
High HB Day 12, n=60, 58	0 0%	0 0%
High HB Day 28, n=57, 58	0 0%	0 0%
High HB Day 56, n=55, 52	0 0%	0 0%
High HB Day 84, n=49, 53	0 0%	0 0%
High HB Follow-up/Early Withdraw, n=54, 53	0 0%	0 0%
Low LC Screening/ Day 1, n=62, 60	9 14.3%	7 11.1%
Low LC Day 12, n=59, 58	2 3.2%	2 3.2%
Low LC Day 28, n=56, 57	3 4.8%	3 4.8%
Low LC Day 56, n=54, 52	2 3.2%	0 0%
Low LC Day 84, n=48, 50	2 3.2%	0 0%
Low LC Follow-up/Early Withdraw, n=53, 53	1 1.6%	1 1.6%
High PC Screening/Day 1, n=63, 63	0 0%	0 0%
High PC Day 12, n=58, 57	0 0%	0 0%
High PC Day 28, n=57, 58	1 1.6%	0 0%
High PC Day 56, n=55, 52	0 0%	0 0%
High PC Day 84, n=49, 53	0 0%	0 0%
High PC Follow-up/Early Withdraw, n=54, 53	0 0%	0 0%
Low PC Screening/ Day 1, n=63, 63	0 0%	0 0%
Low PC Day 12, n=58, 57	0 0%	0 0%
Low PC Day 28, n=57, 58	0 0%	0 0%
Low PC Day 56, n=55, 52	0 0%	0 0%
Low PC Day 84, n=49, 53	0 0%	0 0%
Low PC Follow-up/Early Withdraw, n=54, 53	0 0%	0 0%
Low TN Screening/ Day 1, n=62, 60	0 0%	0 0%
Low TN Day 12, n=59, 58	0 0%	1 1.6%
Low TN Day 28, n=56, 57	0 0%	0 0%
Low TN Day 56, n=54, 52	0 0%	0 0%
Low TN Day 84, n=48, 50	0 0%	0 0%
Low TN Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
High WBC Screening/ Day 1, n=63, 63	0 0%	1 1.6%
High WBC Day 12, n=56, 56	0 0%	1 1.6%
High WBC Day 28, n=56, 57	0 0%	0 0%
High WBC Day 56, n=54, 52	0 0%	0 0%
High WBC Day 84, n=48, 50	0 0%	0 0%
High WBC Follow-up/Early Withdraw, n=53, 53	0 0%	2 3.2%
Low WBC Screening/ Day 1, n=63, 63	0 0%	0 0%
Low WBC Day 12, n=56, 56	0 0%	0 0%
Low WBC Day 28, n=56, 57	0 0%	0 0%
Low WBC Day 56, n=54, 52	0 0%	0 0%
Low WBC Day 84, n=48, 50	0 0%	0 0%
Low WBC Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants With Abnormal Clinical Chemistry Parameters
Description	Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)

Outcome Measure Data

Analysis Population Description

All Subject Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
High ALT Screening/ Day 1, n=63, 63	0 0%	1 1.6%
High ALT Day 12, n=61, 60	0 0%	0 0%
High ALT Day 28, n=58, 60	1 1.6%	0 0%
High ALT Day 56, n=55, 56	0 0%	0 0%
High ALT Day 84, n=52, 55	0 0%	0 0%
High ALT Follow-up/Early Withdraw, n=53, 54	0 0%	0 0%
Low Albumin Screening/ Day 1, n=63, 63	0 0%	0 0%
Low Albumin Day 12, n=61, 60	0 0%	0 0%
Low Albumin Day 28, n=58, 60	0 0%	0 0%
Low Albumin Day 56, n=55, 56	0 0%	0 0%
Low Albumin Day 84, n=52, 55	0 0%	0 0%
Low Albumin Follow-up/Early Withdraw, n=53, 53	1 1.6%	1 1.6%
High ALP Screening/ Day 1, n=63, 63	0 0%	0 0%
High ALP Day 12, n=61, 60	1 1.6%	0 0%
High ALP Day 28, n=58, 60	1 1.6%	0 0%
High ALP Day 56, n=55, 56	0 0%	0 0%
High ALP Day 84, n=52, 55	0 0%	0 0%
High ALP Follow-up/Early Withdraw, n=53, 54	1 1.6%	0 0%
High AST Screening/ Day 1, n=63, 63	0 0%	1 1.6%
High AST Day 12, n=61, 60	0 0%	0 0%
High AST Day 28, n=58, 60	0 0%	0 0%
High AST Day 56, n=55, 56	0 0%	0 0%
High AST Day 84, n=52, 55	0 0%	0 0%
High AST Follow-up/Early Withdraw, n=53, 54	1 1.6%	1 1.6%
High Ca Screening/ Day 1, n=63, 63	0 0%	0 0%
High Ca Day 12, n=61, 60	0 0%	0 0%
High Ca Day 28, n=58, 60	0 0%	0 0%
High Ca Day 56, n=55, 56	0 0%	0 0%
High Ca Day 84, n=52, 55	0 0%	0 0%
High Ca Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
Low Ca Screening/ Day 1, n=63, 63	0 0%	0 0%
Low Ca Day 12, n=61, 60	0 0%	0 0%
Low Ca Day 28, n=58, 60	0 0%	0 0%
Low Ca Day 56, n=55, 56	0 0%	0 0%
Low Ca Day 84, n=52, 55	0 0%	0 0%
Low Ca Follow-up/Early Withdraw, n=53, 53	0 0%	1 1.6%
High Glucose Screening/ Day 1, n=63, 63	6 9.5%	8 12.7%
High Glucose Day 12, n=61, 60	2 3.2%	6 9.5%
High Glucose Day 28, n=58, 60	1 1.6%	3 4.8%
High Glucose Day 56, n=55, 56	3 4.8%	5 7.9%
High Glucose Day 84, n=52, 55	5 7.9%	3 4.8%
High Glucose Follow-up/Early Withdraw, n=53, 53	4 6.3%	6 9.5%
Low Glucose Screening/ Day 1, n=63, 63	0 0%	0 0%
Low Glucose Day 12, n=61, 60	0 0%	0 0%
Low Glucose Day 28, n=58, 60	0 0%	0 0%
Low Glucose Day 56, n=55, 56	0 0%	0 0%
Low Glucose Day 84, n=52, 55	0 0%	0 0%
Low Glucose Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
High Potassium Screening/ Day 1, n=63, 63	1 1.6%	1 1.6%
High Potassium Day 12, n=61, 60	2 3.2%	0 0%
High Potassium Day 28, n=58, 60	2 3.2%	0 0%
High Potassium Day 56, n=55, 56	0 0%	0 0%
High Potassium Day 84, n=52, 550	0 0%	0 0%
High Potassium Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
Low Potassium Screening/ Day 1, n=63, 63	0 0%	0 0%
Low Potassium Day 12, n=61, 60	0 0%	0 0%
Low Potassium V4 Day 28, n=58, 60	0 0%	0 0%
Low Potassium Day 56, n=55, 56	0 0%	0 0%
Low Potassium Day 84, n=52, 55	0 0%	0 0%
Low Potassium Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
High Sodium Screening/ Day 1, n=63, 63	0 0%	0 0%
High Sodium Day 12, n=61, 60	0 0%	0 0%
High Sodium Day 28, n=58, 60	0 0%	0 0%
High Sodium Day 56, n=55, 56	0 0%	0 0%
High Sodium Day 84, n=52, 55	0 0%	0 0%
High Sodium Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
Low Sodium Screening/ Day 1, n=63, 63	1 1.6%	0 0%
Low Sodium Day 12, n=61, 60	1 1.6%	0 0%
Low Sodium Day 28, n=58, 60	0 0%	0 0%
Low Sodium Day 56, n=55, 56	0 0%	0 0%
Low Sodium Day 84, n=52, 55	1 1.6%	0 0%
Low Sodium Follow-up/Early Withdraw, n=53, 53	0 0%	0 0%
High TBL Screening/ Day 1, n=63, 63	1 1.6%	0 0%
High TBL Day 12, n=61, 60	0 0%	0 0%
High TBL Day 28, n=58,60	0 0%	0 0%
High TBL Day 56, n=55, 56	0 0%	0 0%
High TBL Day 84, n=51, 55	0 0%	0 0%
High TBL Follow-up/Early Withdraw, n=53, 54	1 1.6%	1 1.6%

11. Secondary Outcome

Title	Number of Participants With Abnormal Vital Signs
Description	Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)

Outcome Measure Data

Analysis Population Description

All Subject Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
High DBP Screening/Day 1, n=63, 63	1 1.6%	0 0%
High DBP Day 12, n=61, 60	0 0%	0 0%
High DBP Day 28, n=58, 60	0 0%	0 0%
High DBP Day 56, n=55, 56	1 1.6%	0 0%
High DBP Day 84, n=52, 55	0 0%	0 0%
High DBP Follow-up/Early Withdraw, n=55, 60	0 0%	0 0%
High DBP Any Visit Post Baseline, n=62, 62	1 1.6%	0 0%
Low DBP Screening/ Day 1, n=63, 63	0 0%	0 0%
Low DBP Day 12, n=61, 60	1 1.6%	0 0%
Low DBP Day 28, n=58, 60	0 0%	0 0%
Low DBP Day 56, n=55, 56	0 0%	0 0%
Low DBP V6 Day 84, n=52, 55	0 0%	0 0%
Low DBP Follow-up/Early Withdraw, n=55, 60	0 0%	0 0%
Low DBP Any Visit Post Baseline, n=62, 62	1 1.6%	0 0%
High SBP Screening/ Day 1, n=63, 63	2 3.2%	3 4.8%
High SBP Day 12, n=61, 60	0 0%	1 1.6%
High SBP Day 28, n=58, 60	0 0%	0 0%
High SBP Day 56, n=55, 56	2 3.2%	1 1.6%
High SBP Day 84, n=52, 55	1 1.6%	1 1.6%
High SBP Follow-up/Early Withdraw, n=55, 60	1 1.6%	1 1.6%
High SBP Any Visit Post Baseline, n=62, 62	3 4.8%	2 3.2%
Low SBP Screening/ V1 Day 1, n=63, 63	0 0%	0 0%
Low SBP Day 12, n=61, 60	0 0%	0 0%
Low SBP Day 28, n=58, 60	0 0%	0 0%
Low SBP Day 56, n=55, 56	0 0%	0 0%
Low SBP Day 84, n=52, 55	0 0%	0 0%
Low SBP Follow-up/Early Withdraw, n=55, 60	0 0%	0 0%
Low SBP Any Visit Post Baseline, n=62, 62	0 0%	0 0%
High HR Screening/ Day 1, n=63, 63	0 0%	2 3.2%
High HR Day 12, n=61, 60	0 0%	0 0%
High HR Day 28, n=58, 60	2 3.2%	2 3.2%
High HR Day 56, n=55, 56	0 0%	1 1.6%
High HR Day 84, n=52, 55	0 0%	1 1.6%
High HR Follow-up/Early Withdraw, n=55, 60	1 1.6%	1 1.6%
High HR Any Visit Post Baseline, n=62, 62	2 3.2%	3 4.8%
Low HR Screening/ Day 1, n=63, 63	0 0%	0 0%
Low HR Day 12, n=61, 60	0 0%	0 0%
Low HR Day 28, n=58, 60	0 0%	0 0%
Low HR Day 56, n=55, 56	0 0%	0 0%
Low HR Day 84, n=52, 55	0 0%	0 0%
Low HR Follow-up/Early Withdraw, n=55, 60	0 0%	0 0%
Low HR Any Visit Post Baseline, n=62, 62	0 0%	0 0%

12. Secondary Outcome

Title	Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
Description	12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)

Outcome Measure Data

Analysis Population Description

All Subject Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
CN ECG Screening/ Day 1, n=63, 63	45 71.4%	40 63.5%
CS ECG Screening/ Day 1, n=63, 63	0 0%	0 0%
CN ECG Day 12, n=61, 60	43 68.3%	40 63.5%
CS ECG Day 12, n=61, 60	0 0%	0 0%
CN ECG Day 28, n=58, 60	41 65.1%	40 63.5%
CS ECG Day 28, n=58, 60	1 1.6%	1 1.6%
CN ECG Day 56, n=55, 56	36 57.1%	39 61.9%
CS ECG Day 56, n=55, 56	1 1.6%	0 0%
CN ECG Day 84, n=52, 55	36 57.1%	38 60.3%
CS ECG Day 84, n=52, 55	1 1.6%	0 0%
CN ECG Follow-up/Early Withdraw, n=56, 60	35 55.6%	43 68.3%
CS ECG Follow-up/Early Withdraw, n=56, 60	1 1.6%	0 0%
CN ECG Any Visit Post Baseline, n=63, 62	51 81%	51 81%
CS ECG Any Visit Post Baseline, n=63, 62	3 4.8%	1 1.6%

13. Secondary Outcome

Title	Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose
Description	Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.
Time Frame	Pre-dose, 5 min, 3 hrs and 24 hrs

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Population

Arm/Group Title	GSK2269557 1000 mcg
Arm/Group Description	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62
Pre-dose, n=61	33.0 (NA)
5 min, n=60	476.6 (520.85)
3 hrs, n=61	553.7 (326.98)
24 hrs, n=20	539.0 (482.76)

14. Secondary Outcome

Title	Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment
Description	Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Pre-dose Day 12, Day 28, Day 56, and Day 84

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	GSK2269557 1000 mcg
Arm/Group Description	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	62
Pre-dose Day 12, n=57	1001.8 (669.05)
Pre-dose Day 28, n=60	1028.8 (798.38)
Pre-dose Day 56, n=55	1119.8 (1389.53)
Pre-dose Day 84, n=54	948.6 (1078.31)

15. Secondary Outcome

Title	Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily
Description	FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 28, and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n=55, 58	-70.4 (43.07)	-72.2 (41.28)
Day 84, n=46, 54	-83.3 (49.73)	-22.7 (46.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.487
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -118.5 to 115.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Day 28

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.816
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	60.6
	Confidence Interval	(2-Sided) 95%; -73.3 to 194.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Day 84

16. Secondary Outcome

Title	Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily
Description	PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 28, and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n=54, 57	-13.12 (60.421)	-4.76 (57.578)
Day 84, n=45, 53	-0.52 (65.374)	-0.85 (71.170)

17. Secondary Outcome

Title	Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment
Description	DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
DLco Day 28, n=53, 56	-2.783 (9.3950)	-0.687 (8.2655)
DLco Day 84, n=45, 51	-2.385 (9.6016)	0.560 (9.5434)
Kco Day 28, n=53, 55	-2.745 (9.7851)	-0.875 (8.0041)
Kco Day 84, n=45, 50	-2.367 (10.2835)	-0.759 (8.7801)

18. Secondary Outcome

Title	Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment
Description	TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n=53, 59	-0.010	-0.155
Day 84, n=47, 55	-0.149	-0.029

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.151
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.144
	Confidence Interval	(2-Sided) 95%; -0.420 to 0.133
	Parameter Dispersion	Type: Value:
	Estimation Comments	Day 28

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.712
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.121
	Confidence Interval	(2-Sided) 95%; -0.305 to 0.551
	Parameter Dispersion	Type: Value:
	Estimation Comments	Day 84

19. Secondary Outcome

Title	Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment
Description	Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n=53, 59	-0.157	0.022
Day 84, =47, 54	-0.113	0.001

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.817
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.180
	Confidence Interval	(2-Sided) 95%; -0.216 to 0.570
	Parameter Dispersion	Type: Value:
	Estimation Comments	Day 28

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.697
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.114
	Confidence Interval	(2-Sided) 95%; -0.324 to 0.549
	Parameter Dispersion	Type: Value:
	Estimation Comments	Day 84

20. Secondary Outcome

Title	Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment
Description	Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n=52, 59	0.0010 (0.86637)	-0.0919 (0.92501)
Day 84, =46, 55	-0.2219 (1.06874)	-0.0505 (1.41910)

21. Secondary Outcome

Title	Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment
Description	sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n= 17, 17	0.9734 (0.45833)	0.8372 (0.49176)
Day 84, n=11, 13	0.9949 (0.24484)	0.8495 (0.39565)

22. Secondary Outcome

Title	Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment
Description	Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Day 28, n=47, 52	0.875	1.024
Day 84, =40, 47	0.965	1.075

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.965
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	1.171
	Confidence Interval	(2-Sided) 95%; 0.988 to 1.388
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, GSK2269557 1000 mcg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.913
	Comments
	Method	Bayesian repeated measures model
	Comments	Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	1.114
	Confidence Interval	(2-Sided) 95%; 0.953 to 1.305
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Description	The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame	Baseline, Day 28 and Day 84

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
never cough/cough all the time D28, n=58, 60	-0.4 (1.16)	-0.7 (1.14)
never cough/cough all the time D84, n=53, 55	-0.6 (1.48)	-0.7 (0.99)
No phlegm/full of phlegm in chest D28, n=58, 60	-0.6 (1.26)	-0.3 (1.24)
No phlegm/full of phlegm in chest D84, n=53, 55	-0.8 (1.20)	-0.6 (1.18)
No tightness/very tight chest D28, n=58, 60	-0.2 (1.30)	-0.3 (1.16)
No tightness/very tight chest D84, n=53, 55	-0.1 (1.43)	-0.3 (1.34)
Hill/stairs nobreathless/breathlessD28, n=58, 60	-0.5 (0.98)	-0.5 (1.08)
Hill/stairs nobreathless/breathless D84, n=53, 55	-0.4 (1.43)	-0.3 (1.03)
Unlimited/limited home activity D28, n=58, 60	-0.3 (1.43)	-0.3 (1.15)
Unlimited/limited home activity D84, n=53, 55	-0.3 (1.24)	-0.1 (1.39)
Confident/not confident leave home D28, n=58, 60	-0.4 (1.24)	-0.1 (1.27)
Confident/not confident leave homeD84, n=53, 55	-0.2 (1.49)	-0.3 (1.34)
Sound sleep/No sound sleep D28, n=58, 60	-0.4 (1.11)	-0.2 (1.30)
Sound sleep/No sound sleep D84, n=53, 55	-0.3 (1.60)	-0.3 (1.36)
Lot of energy/no energy D28, n=58, 60	-0.1 (1.46)	-0.3 (1.22)
Lot of energy/no energy D84, n=53, 55	-0.2 (1.49)	-0.3 (1.25)
CAT Total Score D28, n=58, 60	-2.9 (6.05)	-2.6 (5.13)
CAT Total Score D84, n=53, 55	-3.0 (7.16)	-3.1 (5.45)
MMRC Dyspnoea Score D28, n=58, 60	-0.4 (0.75)	-0.2 (0.72)
MMRC Dyspnoea Score D84, n=53, 55	-0.4 (0.95)	-0.3 (0.71)

24. Secondary Outcome

Title	Number of Participants With Treatment Failures
Description	Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.
Time Frame	13 weeks

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Placebo	GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.	Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
Measure Participants	63	63
Recurrent exacerbation	17 27%	13 20.6%
Prolonged Treatment of current exacerbation	9 14.3%	7 11.1%
continuation of treatment with SOC/antibiotics	4 6.3%	3 4.8%
Additional treatment with SOC/antibiotics	6 9.5%	6 9.5%
Requirement of invasive mechanical ventilation	0 0%	0 0%

Adverse Events

Time Frame	Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
Adverse Event Reporting Description	SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
Arm/Group Title	Placebo		GSK2269557 1000 mcg
Arm/Group Description	Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.		Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
All Cause Mortality
	Placebo		GSK2269557 1000 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		GSK2269557 1000 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/63 (15.9%)		8/63 (12.7%)
Cardiac disorders
Coronary artery stenosis	0/63 (0%)		1/63 (1.6%)
Gastrointestinal disorders
Constipation	1/63 (1.6%)		0/63 (0%)
General disorders
Malaise	1/63 (1.6%)		0/63 (0%)
Infections and infestations
Lower respiratory tract infection	1/63 (1.6%)		0/63 (0%)
Pneumonia	0/63 (0%)		1/63 (1.6%)
Clostridium difficile infection	0/63 (0%)		1/63 (1.6%)
Investigations
Blood sodium decreased	0/63 (0%)		1/63 (1.6%)
Psychiatric disorders
Anxiety	1/63 (1.6%)		0/63 (0%)
Suicide attempt	1/63 (1.6%)		0/63 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	9/63 (14.3%)		4/63 (6.3%)
Hyperventilation	0/63 (0%)		1/63 (1.6%)
Other (Not Including Serious) Adverse Events
	Placebo		GSK2269557 1000 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/63 (23.8%)		31/63 (49.2%)
Gastrointestinal disorders
Dry mouth	5/63 (7.9%)		2/63 (3.2%)
Nervous system disorders
Headache	5/63 (7.9%)		7/63 (11.1%)
Respiratory, thoracic and mediastinal disorders
Cough	2/63 (3.2%)		22/63 (34.9%)
Vascular disorders
Hypertension	4/63 (6.3%)		0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.