Trial Outcomes & Findings for Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (NCT NCT01000506)

NCT ID: NCT01000506

Last Updated: 2018-01-24

Results Overview

Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids \[OCS\], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 621 participants
• Primary outcome timeframe: From randomization (Week 0) to Week 52 or early withdrawal (EW)
• Results posted on: 2018-01-24

Participant Flow

Participants (par.) who met the eligibility criteria at screening, entered the two week Run-in phase and par. who met the randomization eligibility criteria at the end of the Run-in phase entered into the 52-week Double-blind treatment period followed by a 4-week Follow-up phase. The total duration of participation in the study was 58 Weeks.

A total of 888 par. were enrolled, of these, 168 were screen failures and 720 entered the run-in phase. 99 participants were run-in failures and 621 completed the run-in phase and were randomized. Of these, 616 participants were randomized and received treatment and were included within the Intent-to-Treat (ITT) Population.

Participant milestones

Measure	Placebo IV Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Overall Study STARTED	155	153	152	156
Overall Study COMPLETED	127	129	131	133
Overall Study NOT COMPLETED	28	24	21	23

Reasons for withdrawal

Measure	Placebo IV Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Overall Study Adverse Event	6	5	8	9
Overall Study Lack of Efficacy	8	6	4	4
Overall Study Protocol Violation	1	1	0	0
Overall Study Lost to Follow-up	1	1	4	0
Overall Study Physician Decision	1	3	3	3
Overall Study Withdrawal by Subject	11	8	2	7

Baseline Characteristics

Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma

Baseline characteristics by cohort

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Total n=616 Participants Total of all reporting groups
Age, Continuous	46.4 Years STANDARD_DEVIATION 11.33 • n=5 Participants	50.2 Years STANDARD_DEVIATION 10.84 • n=7 Participants	49.4 Years STANDARD_DEVIATION 11.63 • n=5 Participants	48.6 Years STANDARD_DEVIATION 11.06 • n=4 Participants	48.6 Years STANDARD_DEVIATION 11.28 • n=21 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	104 Participants n=7 Participants	93 Participants n=5 Participants	93 Participants n=4 Participants	387 Participants n=21 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	49 Participants n=7 Participants	59 Participants n=5 Participants	63 Participants n=4 Participants	229 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	6 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	24 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	26 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	137 Participants n=5 Participants	138 Participants n=7 Participants	133 Participants n=5 Participants	139 Participants n=4 Participants	547 Participants n=21 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: From randomization (Week 0) to Week 52 or early withdrawal (EW)

Population: Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.

Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Number of Clinically Significant Exacerbations of Asthma Per Year	2.40 Exacerbations per year	1.24 Exacerbations per year	1.46 Exacerbations per year	1.15 Exacerbations per year

SECONDARY outcome

Timeframe: From randomization (Week 0) to Week 52 or EW

Population: ITT Population

Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit Week 32	60.4 Percentage of participants Interval 52.6 to 68.2	38.2 Percentage of participants Interval 30.9 to 46.7	45.5 Percentage of participants Interval 37.9 to 53.9	39.9 Percentage of participants Interval 32.4 to 48.3
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit Week 52	69.7 Percentage of participants Interval 62.1 to 77.0	48.5 Percentage of participants Interval 40.6 to 57.0	58.3 Percentage of participants Interval 50.4 to 66.4	50.1 Percentage of participants Interval 42.2 to 58.6
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit Week 16	45.2 Percentage of participants Interval 37.7 to 53.5	22.8 Percentage of participants Interval 16.8 to 30.4	26.8 Percentage of participants Interval 20.4 to 34.7	18.9 Percentage of participants Interval 13.5 to 26.1

SECONDARY outcome

Timeframe: From randomization (Week 0) to Week 52 or EW

Population: ITT Population

The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year	0.43 Exacerbations per year	0.17 Exacerbations per year	0.25 Exacerbations per year	0.22 Exacerbations per year

SECONDARY outcome

Timeframe: From randomization (Week 0) to Week 52 or EW

Population: ITT Population

Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Time to First Exacerbation Requiring Hospitalization or ED Visit Week 16	8.6 Percentage of participants Interval 5.1 to 14.3	3.4 Percentage of participants Interval 1.4 to 7.9	6.7 Percentage of participants Interval 3.6 to 12.0	3.9 Percentage of participants Interval 1.8 to 8.5
Time to First Exacerbation Requiring Hospitalization or ED Visit Week 32	14.8 Percentage of participants Interval 10.0 to 21.6	8.3 Percentage of participants Interval 4.8 to 14.1	15.1 Percentage of participants Interval 10.2 to 22.1	8.0 Percentage of participants Interval 4.6 to 13.7
Time to First Exacerbation Requiring Hospitalization or ED Visit Week 52	18.5 Percentage of participants Interval 13.0 to 25.8	10.4 Percentage of participants Interval 6.4 to 16.7	15.9 Percentage of participants Interval 10.8 to 22.9	12.4 Percentage of participants Interval 8.0 to 18.9

SECONDARY outcome

Timeframe: From randomization (Week 0) to Week 52 or EW

Population: ITT Population

Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Number of All Recorded Exacerbations Per Year	2.46 Exacerbations per year	1.34 Exacerbations per year	1.49 Exacerbations per year	1.20 Exacerbations per year

SECONDARY outcome

Timeframe: From randomization (Week 0) to Week 52 or EW

Population: ITT Population

All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Time to First All Recorded Exacerbation Week 16	45.9 Percentage of participants Interval 38.3 to 54.1	26.1 Percentage of participants Interval 19.8 to 33.9	27.5 Percentage of participants Interval 21.0 to 35.4	19.6 Percentage of participants Interval 14.1 to 26.8
Time to First All Recorded Exacerbation Week 52	70.1 Percentage of participants Interval 62.6 to 77.3	52.2 Percentage of participants Interval 44.3 to 60.6	58.3 Percentage of participants Interval 50.4 to 66.4	50.8 Percentage of participants Interval 42.9 to 59.2
Time to First All Recorded Exacerbation Week 32	60.9 Percentage of participants Interval 53.2 to 68.8	41.5 Percentage of participants Interval 34.0 to 49.9	45.5 Percentage of participants Interval 37.8 to 53.9	40.5 Percentage of participants Interval 33.1 to 48.9

SECONDARY outcome

Timeframe: From Baseline up to Week 52 or EW

Population: ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.

FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 8, n=152, 149, 149, 154	154 Milliliters (mL) Standard Error 36.0	165 Milliliters (mL) Standard Error 36.3	133 Milliliters (mL) Standard Error 36.1	142 Milliliters (mL) Standard Error 35.6
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 24, n=136, 138, 141, 141	148 Milliliters (mL) Standard Error 38.7	153 Milliliters (mL) Standard Error 38.7	148 Milliliters (mL) Standard Error 38.3	123 Milliliters (mL) Standard Error 38.0
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 32, n=134, 136, 139, 137	139 Milliliters (mL) Standard Error 37.6	142 Milliliters (mL) Standard Error 37.6	134 Milliliters (mL) Standard Error 37.2	43 Milliliters (mL) Standard Error 37.0
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 36, n=132, 136, 137, 135	88 Milliliters (mL) Standard Error 36.7	138 Milliliters (mL) Standard Error 36.6	133 Milliliters (mL) Standard Error 36.3	119 Milliliters (mL) Standard Error 36.1
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 40, n=129, 133, 135, 135	125 Milliliters (mL) Standard Error 38.9	180 Milliliters (mL) Standard Error 38.8	140 Milliliters (mL) Standard Error 38.4	87 Milliliters (mL) Standard Error 38.1
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 44, n=127, 133, 134, 134	125 Milliliters (mL) Standard Error 37.4	153 Milliliters (mL) Standard Error 37.1	93 Milliliters (mL) Standard Error 36.8	111 Milliliters (mL) Standard Error 36.6
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 48, n=128, 132, 133, 133	91 Milliliters (mL) Standard Error 36.7	140 Milliliters (mL) Standard Error 36.5	123 Milliliters (mL) Standard Error 36.2	112 Milliliters (mL) Standard Error 36.0
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 52, n=127, 129, 129, 132	60 Milliliters (mL) Standard Error 37.7	121 Milliliters (mL) Standard Error 37.6	140 Milliliters (mL) Standard Error 37.3	115 Milliliters (mL) Standard Error 36.9
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 12, n=150, 147, 148, 151	118 Milliliters (mL) Standard Error 36.5	129 Milliliters (mL) Standard Error 36.9	115 Milliliters (mL) Standard Error 36.5	136 Milliliters (mL) Standard Error 36.1
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 16, n=143, 147, 144, 150	135 Milliliters (mL) Standard Error 37.4	137 Milliliters (mL) Standard Error 37.4	97 Milliliters (mL) Standard Error 37.3	94 Milliliters (mL) Standard Error 36.7
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 20, n=141, 144, 142, 147	131 Milliliters (mL) Standard Error 37.3	155 Milliliters (mL) Standard Error 37.3	89 Milliliters (mL) Standard Error 37.1	124 Milliliters (mL) Standard Error 36.6
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 4, n=154, 151, 151, 155	149 Milliliters (mL) Standard Error 35.3	163 Milliliters (mL) Standard Error 35.6	137 Milliliters (mL) Standard Error 35.3	112 Milliliters (mL) Standard Error 34.9
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period Week 28, n=135, 136, 139, 141	125 Milliliters (mL) Standard Error 37.9	176 Milliliters (mL) Standard Error 37.9	89 Milliliters (mL) Standard Error 37.5	95 Milliliters (mL) Standard Error 37.1

SECONDARY outcome

Timeframe: From Baseline up to Week 52 or EW

Population: ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.

FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period Week 16, n=142, 140, 141, 147	59 mL Standard Error 37.6	77 mL Standard Error 37.5	50 mL Standard Error 37.3	87 mL Standard Error 36.3
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period Week 32, n=130, 132, 133, 132	40 mL Standard Error 37.8	49 mL Standard Error 37.5	72 mL Standard Error 37.2	17 mL Standard Error 36.8
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period Week 52, n=126, 128, 129, 130	-9 mL Standard Error 36.7	36 mL Standard Error 36.4	80 mL Standard Error 36.1	69 mL Standard Error 35.6

SECONDARY outcome

Timeframe: From Baseline up to Week 52 or EW

Population: ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.

The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.

Outcome measures

Measure	Placebo IV n=155 Participants Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 Participants Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 Participants Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 Participants Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 8, n=147, 140, 142, 145	-0.50 Scores on a scale Standard Error 0.080	-0.73 Scores on a scale Standard Error 0.081	-0.60 Scores on a scale Standard Error 0.080	-0.65 Scores on a scale Standard Error 0.079
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 12, n=148, 142, 144, 147	-0.63 Scores on a scale Standard Error 0.080	-0.79 Scores on a scale Standard Error 0.081	-0.65 Scores on a scale Standard Error 0.080	-0.72 Scores on a scale Standard Error 0.079
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 16, n=138, 143, 143, 146	-0.59 Scores on a scale Standard Error 0.085	-0.80 Scores on a scale Standard Error 0.085	-0.52 Scores on a scale Standard Error 0.084	-0.76 Scores on a scale Standard Error 0.083
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 20, n=138, 140, 137, 139	-0.59 Scores on a scale Standard Error 0.081	-0.82 Scores on a scale Standard Error 0.081	-0.61 Scores on a scale Standard Error 0.080	-0.72 Scores on a scale Standard Error 0.080
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 24, n=135, 133, 138, 137	-0.66 Scores on a scale Standard Error 0.080	-0.85 Scores on a scale Standard Error 0.080	-0.70 Scores on a scale Standard Error 0.079	-0.79 Scores on a scale Standard Error 0.079
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 28, n=131, 135, 135, 136	-0.70 Scores on a scale Standard Error 0.082	-0.81 Scores on a scale Standard Error 0.081	-0.66 Scores on a scale Standard Error 0.080	-0.73 Scores on a scale Standard Error 0.080
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 52, n=121, 127, 126, 129	-0.59 Scores on a scale Standard Error 0.087	-0.75 Scores on a scale Standard Error 0.087	-0.87 Scores on a scale Standard Error 0.086	-0.80 Scores on a scale Standard Error 0.086
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 4, n=146, 139, 148, 150	-0.45 Scores on a scale Standard Error 0.076	-0.61 Scores on a scale Standard Error 0.077	-0.50 Scores on a scale Standard Error 0.075	-0.56 Scores on a scale Standard Error 0.075
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 32, n=130, 133, 136, 136	-0.62 Scores on a scale Standard Error 0.084	-0.74 Scores on a scale Standard Error 0.084	-0.76 Scores on a scale Standard Error 0.083	-0.74 Scores on a scale Standard Error 0.083
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 36, n=129, 133, 133, 134	-0.60 Scores on a scale Standard Error 0.082	-0.78 Scores on a scale Standard Error 0.082	-0.75 Scores on a scale Standard Error 0.081	-0.76 Scores on a scale Standard Error 0.081
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 40, n=126, 128, 129, 131	-0.64 Scores on a scale Standard Error 0.090	-0.76 Scores on a scale Standard Error 0.090	-0.73 Scores on a scale Standard Error 0.089	-0.67 Scores on a scale Standard Error 0.089
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 44, n=123, 125, 129, 129	-0.62 Scores on a scale Standard Error 0.089	-0.75 Scores on a scale Standard Error 0.089	-0.77 Scores on a scale Standard Error 0.087	-0.69 Scores on a scale Standard Error 0.087
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period Week 48, n=122, 130, 130, 129	-0.63 Scores on a scale Standard Error 0.085	-0.72 Scores on a scale Standard Error 0.084	-0.74 Scores on a scale Standard Error 0.083	-0.68 Scores on a scale Standard Error 0.084

Adverse Events

Placebo IV

Serious events: 25 serious events

Other events: 106 other events

Deaths: 0 deaths

Mepolizumab 75 mg IV

Serious events: 20 serious events

Other events: 113 other events

Deaths: 0 deaths

Mepolizumab 250 mg IV

Serious events: 24 serious events

Other events: 113 other events

Deaths: 0 deaths

Mepolizumab 750 mg IV

Serious events: 19 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo IV n=155 participants at risk Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 participants at risk Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 participants at risk Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 participants at risk Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Respiratory, thoracic and mediastinal disorders Asthma	11.0% 17/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	7.2% 11/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	10.5% 16/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.8% 9/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Lobar pneumonia	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Pneumonia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Bacteraemia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Bronchitis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Cholecystitis infective	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Haematoma infection	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Herpes zoster ophthalmic	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Infected skin ulcer	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Infection	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Lung infection pseudomonal	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Meningitis viral	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Post procedural infection	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Sinusitis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Staphylococcal infection	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Streptococcal bacteraemia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Tonsillitis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Viral upper respiratory tract infection	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Myocardial ischaemia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Atrial flutter	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Coronary artery thrombosis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Coronary artery insufficiency	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Myocardial infarction	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Cardiac disorders Supraventricular tachycardia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Tendon rupture	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Concussion	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Overdose	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Peritoneal haemorrhage	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Nervous system disorders Cerebrovascular accident	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Nervous system disorders Cervicobrachial syndrome	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Nervous system disorders Cranial nerve disorder	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Renal and urinary disorders Nephrolithiasis	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Renal and urinary disorders Haematuria	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Renal and urinary disorders Urinary retention	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Vascular disorders Hypertension	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Vascular disorders Distributive shock	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Vascular disorders Malignant hypertension	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Vascular disorders Venous thrombosis limb	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Chest pain	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Microlithiasis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Investigations Liver function test abnormal	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Investigations Reticulocyte count decreased	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Blood and lymphatic system disorders Leukopenia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Immune system disorders Anaphylactic reaction	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.

Other adverse events

Measure	Placebo IV n=155 participants at risk Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 75 mg IV n=153 participants at risk Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 250 mg IV n=152 participants at risk Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).	Mepolizumab 750 mg IV n=156 participants at risk Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
Infections and infestations Nasopharyngitis	15.5% 24/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	22.2% 34/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	21.7% 33/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	18.6% 29/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	9.7% 15/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	6.5% 10/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	11.2% 17/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	12.2% 19/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Bronchitis	9.7% 15/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	10.5% 16/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	8.6% 13/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	8.3% 13/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Sinusitis	10.3% 16/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	6.5% 10/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	6.6% 10/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	7.7% 12/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Influenza	5.2% 8/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.8% 9/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Urinary tract infection	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.2% 8/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.3% 8/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Respiratory tract infection	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.8% 6/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Rhinitis	4.5% 7/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Lower respiratory tract infection	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Pharyngitis	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.2% 8/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Viral infection	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.8% 6/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Respiratory tract infection viral	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Ear infection	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Acute sinusitis	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Gastroenteritis	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Cystitis	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Viral upper respiratory tract infection	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Tonsillitis	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Infections and infestations Tooth infection	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 11/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.2% 8/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	7.2% 11/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.8% 9/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	6.5% 10/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	6.6% 10/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.1% 8/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.5% 7/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	7.9% 12/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.8% 6/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	4.6% 7/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	4.5% 7/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.8% 6/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.8% 6/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.2% 5/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Nervous system disorders Headache	17.4% 27/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	20.9% 32/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	21.1% 32/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	20.5% 32/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Nervous system disorders Dizziness	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.8% 6/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Nervous system disorders Migraine	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	7.1% 11/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	7.2% 11/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	4.6% 7/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	9.6% 15/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 10/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.9% 9/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.8% 9/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 5/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.1% 8/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	3.2% 5/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.2% 5/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.65% 1/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	6.5% 10/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.2% 8/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	7.9% 12/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	12.2% 19/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Injury, poisoning and procedural complications Ligament sprain	3.9% 6/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	3.9% 6/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	5.1% 8/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Nausea	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	4.6% 7/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	1.9% 3/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Toothache	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.2% 5/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Dyspepsia	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.66% 1/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.2% 5/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.2% 5/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Oedema peripheral	4.5% 7/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Fatigue	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	4.6% 7/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Chest pain	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.65% 1/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	4.6% 7/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Injection site reaction	3.2% 5/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Pyrexia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
General disorders Asthenia	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.3% 5/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.64% 1/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Investigations Blood creatine phosphokinase increased	1.3% 2/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	0.00% 0/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.2% 5/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Vascular disorders Hypertension	4.5% 7/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	3.9% 6/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.6% 4/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.
Immune system disorders Hypersensitivity	2.6% 4/155 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.3% 2/153 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	2.0% 3/152 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.	1.9% 3/156 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose of investigational product until 4 weeks after the last dose of investigational product, up to 52 weeks. SAEs and Non-serious AEs were collected for participants of safety population identical to the ITT population, comprised of all participants who were randomized to treatment and who received at least one dose of study medication.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• 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.
• Publication restrictions are in place

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