Trial Outcomes & Findings for Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia (NCT NCT03433755)

NCT ID: NCT03433755

Last Updated: 2023-03-27

Results Overview

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 259 participants
• Primary outcome timeframe: Baseline, Weeks 10 and 12
• Results posted on: 2023-03-27

Participant Flow

Participants were enrolled at 31 research centers in China from 09 May 2019 to 20 January 2020.

Participants were randomized 2:2:1:1 into the following treatment arms: evolocumab140 mg subcutaneously (SC) every 2 weeks (Q2W); evolocumab 420 mg SC once monthly (QM); placebo SC Q2W, or placebo SC QM. Randomization was stratified by entry cardiovascular (CV) risk (high/very high vs. not high/very high). Due to Human Genetic Resource Administration office of China (HGRAC) regulations/restrictions, 17 participants were not included in any analysis.

Participant milestones

Measure	Placebo Q2W Placebo subcutaneous (SC) Q2W for 12 weeks	Placebo QM Placebo SC QM for 12 weeks	Evolocumab 140 mg Q2W Evolocumab 140 mg SC Q2W for 12 weeks	Evolocumab 420 mg QM Evolocumab 420 mg SC QM for 12 weeks
Overall Study STARTED	42	41	79	80
Overall Study Randomized and Treated	41	41	79	80
Overall Study COMPLETED	40	41	79	80
Overall Study NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Measure	Placebo Q2W Placebo subcutaneous (SC) Q2W for 12 weeks	Placebo QM Placebo SC QM for 12 weeks	Evolocumab 140 mg Q2W Evolocumab 140 mg SC Q2W for 12 weeks	Evolocumab 420 mg QM Evolocumab 420 mg SC QM for 12 weeks
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Decision by Sponsor	1	0	0	0

Baseline Characteristics

Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia

Baseline characteristics by cohort

Measure	Placebo Q2W n=41 Participants Placebo SC Q2W for 12 weeks	Placebo QM n=41 Participants Placebo SC QM for 12 weeks	Evolocumab 140 mg Q2W n=79 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Evolocumab 420 mg QM n=80 Participants Evolocumab 420 mg SC QM for 12 weeks	Total n=241 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 9.8 • n=5 Participants	59.4 years STANDARD_DEVIATION 10.9 • n=7 Participants	61.2 years STANDARD_DEVIATION 10.6 • n=5 Participants	60.9 years STANDARD_DEVIATION 9.8 • n=4 Participants	60.2 years STANDARD_DEVIATION 10.3 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants	29 Participants n=4 Participants	78 Participants n=21 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	31 Participants n=7 Participants	51 Participants n=5 Participants	51 Participants n=4 Participants	163 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants	80 Participants n=4 Participants	241 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	41 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants	80 Participants n=4 Participants	241 Participants n=21 Participants
Stratification Factor: Cardiovascular (CV) Risk High/Very High CV Risk	37 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants	74 Participants n=4 Participants	222 Participants n=21 Participants
Stratification Factor: Cardiovascular (CV) Risk Not High/Very High CV Risk	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	19 Participants n=21 Participants
Low-Density Lipoprotein Cholesterol (LDL-C)	120.9 mg/dL STANDARD_DEVIATION 42.2 • n=5 Participants	117.1 mg/dL STANDARD_DEVIATION 28.2 • n=7 Participants	113.7 mg/dL STANDARD_DEVIATION 37.7 • n=5 Participants	115.5 mg/dL STANDARD_DEVIATION 30.1 • n=4 Participants	116.1 mg/dL STANDARD_DEVIATION 34.6 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12	1.88 percent change Standard Error 3.72	-68.86 percent change Standard Error 3.27	-0.36 percent change Standard Error 3.78	-70.10 percent change Standard Error 3.21

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12	2.48 percent change Standard Error 4.18	-68.39 percent change Standard Error 3.55	2.72 percent change Standard Error 4.25	-63.09 percent change Standard Error 3.42

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Change From Baseline in LDL-C: Mean of Weeks 10 and 12	-0.6 mg/dL Standard Error 5.4	-77.1 mg/dL Standard Error 4.8	-5.8 mg/dL Standard Error 5.8	-83.0 mg/dL Standard Error 5.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Change From Baseline in LDL-C at Week 12	-0.8 mg/dL Standard Error 5.8	-76.7 mg/dL Standard Error 5.1	-2.1 mg/dL Standard Error 6.1	-75.1 mg/dL Standard Error 5.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12	2.36 percent change Standard Error 3.52	-58.84 percent change Standard Error 3.10	-0.06 percent change Standard Error 3.30	-62.20 percent change Standard Error 2.81

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Non-HDL-C at Week 12	3.86 percent change Standard Error 3.85	-57.59 percent change Standard Error 3.30	1.78 percent change Standard Error 3.70	-54.86 percent change Standard Error 2.99

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12	1.80 percent change Standard Error 3.17	-54.45 percent change Standard Error 2.79	0.07 percent change Standard Error 3.00	-56.93 percent change Standard Error 2.54

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in ApoB at Week 12	2.53 percent change Standard Error 3.55	-53.16 percent change Standard Error 3.03	1.20 percent change Standard Error 3.51	-50.01 percent change Standard Error 2.77

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12	1.32 percent change Standard Error 2.74	-41.42 percent change Standard Error 2.42	-0.09 percent change Standard Error 2.68	-44.39 percent change Standard Error 2.28

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Total Cholesterol at Week 12	2.69 percent change Standard Error 2.99	-40.36 percent change Standard Error 2.57	1.17 percent change Standard Error 2.96	-39.25 percent change Standard Error 2.40

SECONDARY outcome

Timeframe: Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.

Percentage of participants who were below the target LDL-C of 70 mg/dL (1.8 mmol/L) based on the mean LDL-C data collected at weeks 10 and 12.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12	2.7 percentage of participants Interval 0.5 to 13.8	89.9 percentage of participants Interval 80.5 to 95.0	5.7 percentage of participants Interval 1.6 to 18.6	97.2 percentage of participants Interval 90.3 to 99.2

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12	0.0 percentage of participants Interval 0.0 to 10.2	90.6 percentage of participants Interval 81.0 to 95.6	3.7 percentage of participants Interval 0.7 to 18.3	89.4 percentage of participants Interval 79.7 to 94.8

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.

Percentage of participants who had LDL-C response (50% reduction of LDL-C from baseline) based on the mean LDL-C using the data collected at weeks 10 and 12.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12	0.0 percentage of participants Interval 0.0 to 9.4	87.0 percentage of participants Interval 77.0 to 93.0	5.7 percentage of participants Interval 1.6 to 18.6	94.4 percentage of participants Interval 86.4 to 97.8

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.

LDL-C Response is defined as a 50% reduction of LDL-C from Baseline.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12	0.0 percentage of participants Interval 0.0 to 10.2	82.8 percentage of participants Interval 71.8 to 90.1	3.7 percentage of participants Interval 0.7 to 18.3	86.4 percentage of participants Interval 76.1 to 92.7

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12	4.96 percent change Standard Error 4.97	-43.49 percent change Standard Error 4.46	11.27 percent change Standard Error 4.37	-29.16 percent change Standard Error 3.58

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Lp(a) at Week 12	1.87 percent change Standard Error 5.21	-42.83 percent change Standard Error 4.60	14.53 percent change Standard Error 5.64	-23.73 percent change Standard Error 4.18

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12	5.23 percent change Standard Error 4.77	-9.86 percent change Standard Error 4.19	3.03 percent change Standard Error 4.85	-16.64 percent change Standard Error 4.09

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Triglycerides at Week 12	10.01 percent change Standard Error 5.63	-7.55 percent change Standard Error 4.73	0.69 percent change Standard Error 5.56	-11.66 percent change Standard Error 4.37

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12	1.01 percent change Standard Error 2.65	9.45 percent change Standard Error 2.35	1.86 percent change Standard Error 2.60	8.66 percent change Standard Error 2.18

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in HDL-C at Week 12	1.95 percent change Standard Error 2.88	9.89 percent change Standard Error 2.49	0.95 percent change Standard Error 2.97	7.12 percent change Standard Error 2.33

SECONDARY outcome

Timeframe: Baseline, Weeks 10 and 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=37 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=69 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=35 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=71 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12	7.08 percent change Standard Error 5.32	-15.88 percent change Standard Error 4.73	4.95 percent change Standard Error 4.97	-22.87 percent change Standard Error 4.21

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.

Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo Q2W n=34 Participants Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=64 Participants Evolocumab 140 mg SC Q2W for 12 weeks	Placebo QM n=27 Participants Placebo SC QM for 12 weeks	Evolocumab 420 mg QM n=66 Participants Evolocumab 420 mg SC QM for 12 weeks
Percent Change From Baseline in VLDL-C at Week 12	11.23 percent change Standard Error 6.12	-10.55 percent change Standard Error 5.22	1.72 percent change Standard Error 5.57	-14.02 percent change Standard Error 4.42

Adverse Events

Placebo Q2W

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo QM

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Evolocumab 140 mg Q2W

Serious events: 6 serious events

Other events: 45 other events

Deaths: 0 deaths

Evolocumab 420 mg QM

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Q2W n=41 participants at risk Placebo SC Q2W for 12 weeks	Placebo QM n=41 participants at risk Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=79 participants at risk Evolocumab 140 mg SC Q2W for 12 weeks	Evolocumab 420 mg QM n=80 participants at risk Evolocumab 420 mg SC QM for 12 weeks
Cardiac disorders Acute myocardial infarction	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiogenic shock	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Endocrine disorders Goitre	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Periarthritis	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Hypertension	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Shock haemorrhagic	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.

Other adverse events

Measure	Placebo Q2W n=41 participants at risk Placebo SC Q2W for 12 weeks	Placebo QM n=41 participants at risk Placebo SC Q2W for 12 weeks	Evolocumab 140 mg Q2W n=79 participants at risk Evolocumab 140 mg SC Q2W for 12 weeks	Evolocumab 420 mg QM n=80 participants at risk Evolocumab 420 mg SC QM for 12 weeks
Blood and lymphatic system disorders Abnormal clotting factor	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiomegaly	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Left atrial enlargement	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Left ventricular dysfunction	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Mitral valve incompetence	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	4.9% 2/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Endocrine disorders Goitre	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Aphthous ulcer	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Chronic gastritis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Enteritis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric polyps	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Toothache	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
General disorders Facial pain	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
General disorders Feeling cold	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	7.3% 3/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Congestive hepatopathy	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic cyst	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic mass	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	4.9% 2/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	4.9% 2/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Conjunctivitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Helicobacter infection	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Influenza	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Otitis media	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Periodontitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Syphilis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	12.2% 5/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	4.9% 2/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	8.9% 7/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	7.5% 6/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	4.9% 2/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Muscle injury	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tooth fracture	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Bacterial test	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Bacterial test positive	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Bilirubin conjugated increased	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood bilirubin unconjugated increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood glucose increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood pressure increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Blood urea increased	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Body temperature increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Carotid intima-media thickness increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Glucose urine present	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Liver function test abnormal	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Protein urine present	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	5.1% 4/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Transaminases increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Urinary occult blood positive	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations White blood cells urine positive	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Investigations pH urine increased	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypovitaminosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	4.9% 2/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Carotid artery stenosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Dizziness	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Psychiatric disorders Mental disorder	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Psychiatric disorders Sleep disorder	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Microalbuminuria	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Proteinuria	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Renal cyst	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Breast swelling	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatic calcification	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.2% 1/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria papular	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Arteriosclerosis	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Blood pressure inadequately controlled	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	3.8% 3/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Hypertension	2.4% 1/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	7.3% 3/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	7.6% 6/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	5.0% 4/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Vascular wall hypertrophy	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	2.5% 2/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.
Vascular disorders Venous thrombosis limb	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/41 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	1.3% 1/79 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.	0.00% 0/80 • Mortality: from randomization to end of study (EOS) date; median (min, max) duration was 3.22 (0.99, 4.01) months. AEs: from first dose up to last dose + 30 days or EOS date, whichever was earlier; median (min, max) duration was 2.86 (1.02, 3.88) months. Mortality is reported for randomized participants. Serious and other AEs are reported for randomized participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER