Trial Outcomes & Findings for A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01053988)

Last Updated: 2018-07-12

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

1031 participants

Primary outcome timeframe

Baseline (BL) to Day 168

Results posted on

2018-07-12

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 1804 par. were screened, 1390 entered the RIP, of whom 1031 were randomized, 1030 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.	VI 25 µg OD Participants received Vilanterol (VI \[GW642444\]) 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD Participants received FF/VI 50/25 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.
2-week, Single-blind Run-In Period STARTED	1390	0	0	0	0	0
2-week, Single-blind Run-In Period COMPLETED	1030	0	0	0	0	0
2-week, Single-blind Run-In Period NOT COMPLETED	360	0	0	0	0	0
24-week, Double-blind Treatment Period STARTED	0	207	206	205	206	206
24-week, Double-blind Treatment Period COMPLETED	0	138	145	142	147	151
24-week, Double-blind Treatment Period NOT COMPLETED	0	69	61	63	59	55

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.	VI 25 µg OD Participants received Vilanterol (VI \[GW642444\]) 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD Participants received FF/VI 50/25 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.
2-week, Single-blind Run-In Period Did Not Meet Continuation Criteria	220	0	0	0	0	0
2-week, Single-blind Run-In Period Study Closed/Terminated	98	0	0	0	0	0
2-week, Single-blind Run-In Period Withdrawal by Subject	30	0	0	0	0	0
2-week, Single-blind Run-In Period Adverse Event	6	0	0	0	0	0
2-week, Single-blind Run-In Period Physician Decision	5	0	0	0	0	0
2-week, Single-blind Run-In Period Lost to Follow-up	1	0	0	0	0	0
24-week, Double-blind Treatment Period Adverse Event	0	15	23	24	17	14
24-week, Double-blind Treatment Period Lack of Efficacy-No Sub-Reason	0	3	2	2	3	0
24-week, Double-blind Treatment Period Lack of Efficacy-Sub-Reason Exacerbation	0	17	16	13	9	12
24-week, Double-blind Treatment Period Protocol Violation	0	3	4	2	1	4
24-week, Double-blind Treatment Period Met Protocol-Defined Stopping Criteria	0	11	5	8	13	9
24-week, Double-blind Treatment Period Lost to Follow-up	0	4	0	2	1	3
24-week, Double-blind Treatment Period Physician Decision	0	5	2	5	5	4
24-week, Double-blind Treatment Period Withdrawal by Subject	0	11	9	7	10	9

Baseline Characteristics

A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=207 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=206 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=205 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=206 Participants Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=206 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.	Total n=1030 Participants Total of all reporting groups
Race/Ethnicity, Customized Central/South Asian HER	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER	44 Participants n=5 Participants	64 Participants n=7 Participants	56 Participants n=5 Participants	43 Participants n=4 Participants	46 Participants n=21 Participants	253 Participants n=8 Participants
Race/Ethnicity, Customized White	155 Participants n=5 Participants	139 Participants n=7 Participants	141 Participants n=5 Participants	156 Participants n=4 Participants	150 Participants n=21 Participants	741 Participants n=8 Participants
Age, Continuous	62.1 Years STANDARD_DEVIATION 8.80 • n=5 Participants	62.7 Years STANDARD_DEVIATION 9.47 • n=7 Participants	63.4 Years STANDARD_DEVIATION 9.58 • n=5 Participants	62.8 Years STANDARD_DEVIATION 9.13 • n=4 Participants	62.3 Years STANDARD_DEVIATION 8.49 • n=21 Participants	62.7 Years STANDARD_DEVIATION 9.09 • n=8 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	74 Participants n=7 Participants	65 Participants n=5 Participants	71 Participants n=4 Participants	69 Participants n=21 Participants	345 Participants n=8 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	132 Participants n=7 Participants	140 Participants n=5 Participants	135 Participants n=4 Participants	137 Participants n=21 Participants	685 Participants n=8 Participants
Race/Ethnicity, Customized African American/African Heritage (HER)	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	32 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 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=139 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=145 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=144 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=146 Participants Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=151 Participants Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168	0.026 Liters Standard Error 0.0184	0.080 Liters Standard Error 0.0182	0.129 Liters Standard Error 0.0182	0.218 Liters Standard Error 0.0181	0.200 Liters Standard Error 0.0179

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=136 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=143 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=143 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=144 Participants Participants received FF/VI 50/25 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.
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169	0.037 Liters Standard Error 0.0199	0.070 Liters Standard Error 0.0196	0.103 Liters Standard Error 0.0196	0.166 Liters Standard Error 0.0196	0.151 Liters Standard Error 0.0194

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=135 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=143 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=140 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=145 Participants Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=147 Participants Participants received FF/VI 100/25 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	0.23 Scores on a scale Standard Error 0.088	0.29 Scores on a scale Standard Error 0.086	0.37 Scores on a scale Standard Error 0.086	0.42 Scores on a scale Standard Error 0.085	0.53 Scores on a scale Standard Error 0.085

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=207 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=206 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=205 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=205 Participants Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=206 Participants Participants received FF/VI 100/25 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	0.106 Liters Standard Error 0.0098	0.118 Liters Standard Error 0.0099	0.247 Liters Standard Error 0.0099	0.253 Liters Standard Error 0.0099	0.245 Liters Standard Error 0.0099

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=207 Participants Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=206 Participants Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=205 Participants Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=205 Participants Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=206 Participants Participants received FF/VI 100/25 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.	NA Minutes Interval 5.0 to 240.0 \> 50% of participants were censored; therefore, the median could not be calculated.	16 Minutes Interval 5.0 to 240.0	17 Minutes Interval 5.0 to 240.0	17 Minutes Interval 5.0 to 240.0

Adverse Events

Placebo

Serious events: 11 serious events

Other events: 37 other events

Deaths: 0 deaths

FF 100 µg OD

Serious events: 16 serious events

Other events: 59 other events

Deaths: 0 deaths

VI 25 µg OD

Serious events: 15 serious events

Other events: 53 other events

Deaths: 0 deaths

FF/VI 50/25 µg OD

Serious events: 6 serious events

Other events: 52 other events

Deaths: 0 deaths

FF/VI 100/25 µg OD

Serious events: 11 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=207 participants at risk Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=206 participants at risk Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=205 participants at risk Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=206 participants at risk Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=206 participants at risk Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 3/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.97% 2/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	2.9% 6/205 • 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	1.9% 4/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.97% 2/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Gastroenteritis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 pneumococcal	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Alcohol poisoning	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Fractured coccyx	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Multiple fractures	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Multiple injuries	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Radius fracture	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Road traffic accident	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Transplant failure	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Vascular pseudoaneurysm	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Carotid artery stenosis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.97% 2/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Ischaemic stroke	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.97% 2/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 haemorrhage	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Hypertonia	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Intracranial aneurysm	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Myasthenia gravis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Subarachnoid haemorrhage	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Transient ischaemic attack	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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) Glottis carcinoma	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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) Lip and/or oral cavity cancer	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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) Nasopharyngeal cancer stage IV	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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) Small cell lung cancer stage unspecified	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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) Transitional cell carcinoma	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Angina unstable	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Coronary artery disease	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Colitis	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Gastrointestinal haemorrhage	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Sudden cardiac death	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Dehydration	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Cervical spinal stenosis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Intervertebral disc disorder	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication
Renal and urinary disorders Nephrolithiasis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication
Renal and urinary disorders Renal failure acute	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Arteriosclerosis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Peripheral arterial occlusive disease	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Deafness neurosensory	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication
Hepatobiliary disorders Cholangitis	0.00% 0/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.00% 0/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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=207 participants at risk Participants received placebo OD in the morning from the DPI for 24 weeks.	FF 100 µg OD n=206 participants at risk Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.	VI 25 µg OD n=205 participants at risk Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 50/25 µg OD n=206 participants at risk Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.	FF/VI 100/25 µg OD n=206 participants at risk Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
Infections and infestations Nasopharyngitis	6.8% 14/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	8.7% 18/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	10.7% 22/205 • 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	6.8% 14/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	10.7% 22/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	3.9% 8/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 13/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 11/205 • 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	7.8% 16/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	10.2% 21/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.97% 2/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	1.9% 4/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.98% 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	4.9% 10/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	2.9% 6/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.48% 1/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.97% 2/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	3.9% 8/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	1.9% 4/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Sinusitis	0.97% 2/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 7/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	1.9% 4/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Lower respiratory tract infection	3.4% 7/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	1.5% 3/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	2.4% 5/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	8.3% 17/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	7.8% 16/205 • 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	5.8% 12/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	8.7% 18/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Back pain	1.9% 4/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 5/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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	3.4% 7/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	2.9% 6/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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 Arthralgia	0.97% 2/207 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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% 7/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.98% 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	0.49% 1/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication	0.97% 2/206 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication through the end of treatment (up to Week 24). An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were 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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