Trial Outcomes & Findings for Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01054885)

Last Updated: 2018-01-24

Results Overview

Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes \[min\] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1226 participants

Primary outcome timeframe

Baseline (BL) to Day 168

Results posted on

2018-01-24

Participant Flow

Eligible participants (par.) completed a 2-week single-blind (placebo) Run-in Period (RIP) to assess Baseline rescue use, symptoms, disease stability. Par. were then randomized to a 24-week Treatment Period. A total of 1909 par. were screened, 1577 entered the RIP, of whom 1226 were randomized, 1224 received at least one dose of study medication.

Participant milestones

Participant milestones
Measure	Placebo Run-in Participants received placebo once daily (OD) in the morning for 2 weeks.	Placebo Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.	FF 100 µg OD Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.	FF 200 µg OD Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD Participants received Vilanterol (VI \[GW642444\]) 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
2-week, Single-blind Run-In Period STARTED	1577	0	0	0	0	0	0
2-week, Single-blind Run-In Period COMPLETED	1226	0	0	0	0	0	0
2-week, Single-blind Run-In Period NOT COMPLETED	351	0	0	0	0	0	0
24-week, Double-blind Treatment Period STARTED	0	205	204	203	203	204	205
24-week, Double-blind Treatment Period COMPLETED	0	146	155	160	161	144	158
24-week, Double-blind Treatment Period NOT COMPLETED	0	59	49	43	42	60	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Run-in Participants received placebo once daily (OD) in the morning for 2 weeks.	Placebo Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.	FF 100 µg OD Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.	FF 200 µg OD Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD Participants received Vilanterol (VI \[GW642444\]) 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
2-week, Single-blind Run-In Period Did Not Meet Continuation Criteria	246	0	0	0	0	0	0
2-week, Single-blind Run-In Period Physician Decision	6	0	0	0	0	0	0
2-week, Single-blind Run-In Period Withdrawal by Subject	23	0	0	0	0	0	0
2-week, Single-blind Run-In Period Lost to Follow-up	1	0	0	0	0	0	0
2-week, Single-blind Run-In Period Adverse Event	7	0	0	0	0	0	0
2-week, Single-blind Run-In Period Study Closed/Terminated	68	0	0	0	0	0	0
24-week, Double-blind Treatment Period Adverse Event	0	18	12	15	15	17	19
24-week, Double-blind Treatment Period Lack of Efficacy-No Sub-Reason	0	0	3	1	0	1	0
24-week, Double-blind Treatment Period Lack of Efficacy-Sub-Reason Exacerbation	0	12	2	5	11	7	7
24-week, Double-blind Treatment Period Protocol Violation	0	7	7	2	3	8	4
24-week, Double-blind Treatment Period Protocol Defined Stopping Criteria	0	7	12	7	7	15	12
24-week, Double-blind Treatment Period Study Closed/ Terminated	0	0	1	0	0	0	1
24-week, Double-blind Treatment Period Lost to Follow-up	0	3	2	0	0	2	1
24-week, Double-blind Treatment Period Physician Decision	0	4	1	6	3	1	1
24-week, Double-blind Treatment Period Withdrawal by Subject	0	8	9	7	3	9	2

Baseline Characteristics

Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=205 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=204 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=203 Participants Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=203 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=204 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=205 Participants Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.	Total n=1224 Participants Total of all reporting groups
Age, Continuous	61.9 Years STANDARD_DEVIATION 8.14 • n=5 Participants	61.8 Years STANDARD_DEVIATION 8.28 • n=7 Participants	61.8 Years STANDARD_DEVIATION 9.02 • n=5 Participants	61.2 Years STANDARD_DEVIATION 8.62 • n=4 Participants	61.9 Years STANDARD_DEVIATION 8.79 • n=21 Participants	61.1 Years STANDARD_DEVIATION 8.67 • n=8 Participants	61.6 Years STANDARD_DEVIATION 8.58 • n=8 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	54 Participants n=7 Participants	52 Participants n=5 Participants	52 Participants n=4 Participants	60 Participants n=21 Participants	68 Participants n=8 Participants	339 Participants n=8 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	150 Participants n=7 Participants	151 Participants n=5 Participants	151 Participants n=4 Participants	144 Participants n=21 Participants	137 Participants n=8 Participants	885 Participants n=8 Participants
Race/Ethnicity, Customized African American/African Heritage (HER)	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	16 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER	8 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	11 Participants n=8 Participants	50 Participants n=8 Participants
Race/Ethnicity, Customized White	197 Participants n=5 Participants	197 Participants n=7 Participants	183 Participants n=5 Participants	196 Participants n=4 Participants	190 Participants n=21 Participants	192 Participants n=8 Participants	1155 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline (BL) to Day 168

Population: Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis

Outcome measures

Outcome measures
Measure	Placebo n=147 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=154 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=162 Participants Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=160 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=146 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=158 Participants Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168	-0.012 Liters Standard Error 0.0189	0.034 Liters Standard Error 0.0187	0.029 Liters Standard Error 0.0185	0.173 Liters Standard Error 0.0184	0.202 Liters Standard Error 0.0190	0.197 Liters Standard Error 0.0184

PRIMARY outcome

Timeframe: Baseline to Day 169

Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

Outcome measures

Outcome measures
Measure	Placebo n=142 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=148 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=155 Participants Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=150 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=137 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=153 Participants Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169	0.004 Liters Standard Error 0.0189	0.048 Liters Standard Error 0.0187	0.012 Liters Standard Error 0.0185	0.103 Liters Standard Error 0.0185	0.148 Liters Standard Error 0.0191	0.135 Liters Standard Error 0.0185

SECONDARY outcome

Timeframe: Baseline to Day 168

Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.

Outcome measures

Outcome measures
Measure	Placebo n=146 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=154 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=161 Participants Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=161 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=146 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=156 Participants Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168	0.21 Scores on a scale Standard Error 0.077	0.10 Scores on a scale Standard Error 0.076	0.21 Scores on a scale Standard Error 0.075	0.28 Scores on a scale Standard Error 0.075	0.45 Scores on a scale Standard Error 0.078	0.31 Scores on a scale Standard Error 0.075

SECONDARY outcome

Timeframe: Baseline and Day 1

Population: Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=203 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=202 Participants Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=201 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=203 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=205 Participants Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1	0.120 Liters Standard Error 0.0108	0.144 Liters Standard Error 0.0109	0.127 Liters Standard Error 0.0109	0.267 Liters Standard Error 0.0109	0.272 Liters Standard Error 0.0109	0.261 Liters Standard Error 0.0108

SECONDARY outcome

Timeframe: Baseline and Day 1

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.

Outcome measures

Outcome measures
Measure	Placebo n=204 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=203 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=202 Participants Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=201 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=203 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=205 Participants Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1	NA Minutes Interval 5.0 to 240.0 \> 50% of participants were censored; therefore, the median could not be calculated.	231 Minutes Interval 5.0 to 240.0	242 Minutes Interval 5.0 to 242.0	17 Minutes Interval 5.0 to 240.0	16 Minutes Interval 5.0 to 240.0	17 Minutes Interval 5.0 to 240.0

Adverse Events

Placebo

Serious events: 10 serious events

Other events: 39 other events

Deaths: 0 deaths

FF 100 µg OD

Serious events: 6 serious events

Other events: 32 other events

Deaths: 0 deaths

FF 200 µg OD

Serious events: 10 serious events

Other events: 46 other events

Deaths: 0 deaths

VI 25 µg OD

Serious events: 16 serious events

Other events: 43 other events

Deaths: 0 deaths

FF/VI 100/25 µg OD

Serious events: 12 serious events

Other events: 36 other events

Deaths: 0 deaths

FF/VI 200/25 µg OD

Serious events: 15 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=205 participants at risk Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=204 participants at risk Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=203 participants at risk Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=203 participants at risk Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=204 participants at risk Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=205 participants at risk Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.4% 5/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.99% 2/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.5% 5/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.5% 5/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.4% 5/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Pneumonia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.99% 2/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.99% 2/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	1.5% 3/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Infective exacerbation of chronic obstructive airway disease	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Appendicitis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Sepsis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Myocardial infarction	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Atrioventricular block first degree	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Bradycardia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Cardiac failure chronic	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Cardiac failure congestive	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Myocardial ischaemia	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Abdominal hernia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Enteritis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Hiatus hernia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Inguinal hernia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Oesophagitis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Peritonitis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Gastrointestinal disorders Rectal haemorrhage	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Injury, poisoning and procedural complications Accidental poisoning	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Nervous system disorders Syncope	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.99% 2/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Nervous system disorders Cerebral infarction	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Nervous system disorders Cerebrovascular accident	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Nervous system disorders Thrombotic stroke	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
General disorders Chest discomfort	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
General disorders Device occlusion	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Immune system disorders Anaphylactic reaction	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Vascular disorders Venous insufficiency	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.

Other adverse events

Other adverse events
Measure	Placebo n=205 participants at risk Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=204 participants at risk Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	FF 200 µg OD n=203 participants at risk Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=203 participants at risk Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=204 participants at risk Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 200/25 µg OD n=205 participants at risk Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
Infections and infestations Nasopharyngitis	8.3% 17/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	6.9% 14/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	9.9% 20/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	9.4% 19/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	6.4% 13/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	6.3% 13/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Upper respiratory tract infection	2.4% 5/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	1.5% 3/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.5% 5/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	4.4% 9/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	3.9% 8/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	3.4% 7/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Oral candidiasis	0.98% 2/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.5% 5/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.5% 5/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.99% 2/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	3.9% 8/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.0% 4/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Infections and infestations Oropharyngeal candidiasis	1.5% 3/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	3.4% 7/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	1.5% 3/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	2.0% 4/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Nervous system disorders Headache	7.3% 15/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	6.4% 13/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	5.4% 11/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	9.9% 20/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	5.4% 11/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	7.3% 15/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
Vascular disorders Hypertension	1.5% 3/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	1.5% 3/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	3.4% 7/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.00% 0/203 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	1.5% 3/204 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.	0.49% 1/205 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.

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Principal investigator is a sponsor employee 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.
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