Trial Outcomes & Findings for Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants (NCT NCT02166047)

Last Updated: 2020-10-14

Results Overview

A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (\> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

162 participants

Primary outcome timeframe

Baseline to Week 24

Results posted on

2020-10-14

Participant Flow

Participants were enrolled at study sites in the United States, Canada, Italy, South Korea, The Netherlands, and New Zealand. The first participant was screened on 30 June 2014. The last study visit occurred on 20 October 2016.

All participants continued their approved HBV oral antiviral therapy (tenofovir disoproxil fumarate (TDF), entecavir (ETV), adefovir, lamivudine, or telbivudine, either as single agents or in combination) throughout the study. 200 participants were screened.

Participant milestones

Participant milestones
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) Placebo tablet once a week for 12 weeks
Overall Study STARTED	16	15	16	5	18	17	17	5	16	17	14	6
Overall Study COMPLETED	16	14	14	5	17	17	15	5	16	17	12	6
Overall Study NOT COMPLETED	0	1	2	0	1	0	2	0	0	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) Placebo tablet once a week for 12 weeks
Overall Study Withdrawal by Participant	0	1	2	0	0	0	1	0	0	0	0	0
Overall Study Adverse Event	0	0	0	0	1	0	1	0	0	0	2	0

Baseline Characteristics

Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=18 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=14 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks	Total n=162 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 7.3 • n=5 Participants	50 years STANDARD_DEVIATION 11.2 • n=7 Participants	47 years STANDARD_DEVIATION 10.0 • n=5 Participants	53 years STANDARD_DEVIATION 5.3 • n=4 Participants	51 years STANDARD_DEVIATION 8.2 • n=21 Participants	44 years STANDARD_DEVIATION 9.0 • n=8 Participants	44 years STANDARD_DEVIATION 11.1 • n=8 Participants	53 years STANDARD_DEVIATION 5.4 • n=24 Participants	48 years STANDARD_DEVIATION 9.8 • n=42 Participants	48 years STANDARD_DEVIATION 9.7 • n=42 Participants	50 years STANDARD_DEVIATION 11.6 • n=42 Participants	46 years STANDARD_DEVIATION 10.9 • n=42 Participants	48 years STANDARD_DEVIATION 9.7 • n=36 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	39 Participants n=36 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants	13 Participants n=8 Participants	13 Participants n=8 Participants	4 Participants n=24 Participants	11 Participants n=42 Participants	15 Participants n=42 Participants	11 Participants n=42 Participants	6 Participants n=42 Participants	123 Participants n=36 Participants
Race/Ethnicity, Customized Race · Asian	13 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants	15 Participants n=8 Participants	16 Participants n=8 Participants	4 Participants n=24 Participants	9 Participants n=42 Participants	8 Participants n=42 Participants	9 Participants n=42 Participants	2 Participants n=42 Participants	117 Participants n=36 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	7 Participants n=42 Participants	8 Participants n=42 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	34 Participants n=36 Participants
Race/Ethnicity, Customized Race · White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	7 Participants n=36 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized Race · Other	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	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	16 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants	17 Participants n=8 Participants	17 Participants n=8 Participants	5 Participants n=24 Participants	16 Participants n=42 Participants	17 Participants n=42 Participants	14 Participants n=42 Participants	6 Participants n=42 Participants	162 Participants n=36 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	33 Participants n=36 Participants
Region of Enrollment Italy	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	9 Participants n=42 Participants	8 Participants n=42 Participants	9 Participants n=42 Participants	2 Participants n=42 Participants	28 Participants n=36 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=36 Participants
Region of Enrollment New Zealand	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	24 Participants n=36 Participants
Region of Enrollment South Korea	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=8 Participants	9 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	28 Participants n=36 Participants
Region of Enrollment United States	4 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	43 Participants n=36 Participants
Serum Hepatitis B Surface Antigen (HBsAg) Level	2.8 log10 IU/mL STANDARD_DEVIATION 0.88 • n=5 Participants	3.1 log10 IU/mL STANDARD_DEVIATION 0.59 • n=7 Participants	3.0 log10 IU/mL STANDARD_DEVIATION 0.70 • n=5 Participants	3.1 log10 IU/mL STANDARD_DEVIATION 0.69 • n=4 Participants	3.1 log10 IU/mL STANDARD_DEVIATION 0.62 • n=21 Participants	3.0 log10 IU/mL STANDARD_DEVIATION 0.69 • n=8 Participants	3.1 log10 IU/mL STANDARD_DEVIATION 0.90 • n=8 Participants	2.7 log10 IU/mL STANDARD_DEVIATION 0.73 • n=24 Participants	3.3 log10 IU/mL STANDARD_DEVIATION 0.45 • n=42 Participants	3.0 log10 IU/mL STANDARD_DEVIATION 0.54 • n=42 Participants	3.0 log10 IU/mL STANDARD_DEVIATION 0.69 • n=42 Participants	2.4 log10 IU/mL STANDARD_DEVIATION 1.01 • n=42 Participants	3.0 log10 IU/mL STANDARD_DEVIATION 0.70 • n=36 Participants
Serum HBsAg Level Categories ≤ 5000 IU/mL	13 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	4 Participants n=4 Participants	15 Participants n=21 Participants	15 Participants n=8 Participants	14 Participants n=8 Participants	5 Participants n=24 Participants	14 Participants n=42 Participants	15 Participants n=42 Participants	13 Participants n=42 Participants	5 Participants n=42 Participants	139 Participants n=36 Participants
Serum HBsAg Level Categories > 5000 IU/mL	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	23 Participants n=36 Participants
Hepatitis B Envelope Antigen (HBeAg) Status Negative	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=8 Participants	14 Participants n=8 Participants	5 Participants n=24 Participants	13 Participants n=42 Participants	14 Participants n=42 Participants	12 Participants n=42 Participants	4 Participants n=42 Participants	128 Participants n=36 Participants
Hepatitis B Envelope Antigen (HBeAg) Status Positive	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	34 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: Participants in the Full Analysis Set (participants who were randomized and received at least 1 dose of study drug) with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=14 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=16 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=12 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Level at Week 24	-0.011 log10 IU/mL Interval -0.054 to 0.031	0.033 log10 IU/mL Interval -0.012 to 0.079	-0.018 log10 IU/mL Interval -0.062 to 0.026	-0.035 log10 IU/mL Interval -0.109 to 0.04	-0.081 log10 IU/mL Interval -0.145 to -0.016	-0.081 log10 IU/mL Interval -0.147 to -0.014	-0.082 log10 IU/mL Interval -0.148 to -0.015	-0.163 log10 IU/mL Interval -0.281 to -0.045	-0.015 log10 IU/mL Interval -0.057 to 0.027	0.000 log10 IU/mL Interval -0.041 to 0.042	0.000 log10 IU/mL Interval -0.046 to 0.047	0.001 log10 IU/mL Interval -0.057 to 0.058

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with HBeAg+ at Baseline were analyzed.

HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg seroconversion was defined as qualitative hepatitis B envelope antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=4 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=4 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=4 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=1 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=5 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=3 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=3 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=3 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=3 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=2 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=2 Participants Placebo tablet once a week for 12 weeks
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 24	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set with HBeAg+ at Baseline were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=4 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=4 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=4 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=1 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=5 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=3 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=3 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=3 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=3 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=2 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=2 Participants Placebo tablet once a week for 12 weeks
Composite Endpoint Measuring the Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss and Seroconversion at Week 48	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	33.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg seroconversion was defined as qualitative hepatitis B surface antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit within the targeted time window. Participants who had missing information were assumed to have no HBsAg loss and no HBsAg seroconversion.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=18 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=14 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=18 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=14 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and Seroconversion at Week 48	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 4

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=14 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=14 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=18 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=13 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Change From Baseline in Serum HBsAg Level at Week 4	-0.009 log10 IU/mL Standard Deviation 0.0505	0.025 log10 IU/mL Standard Deviation 0.0514	-0.008 log10 IU/mL Standard Deviation 0.0516	-0.017 log10 IU/mL Standard Deviation 0.0600	-0.003 log10 IU/mL Standard Deviation 0.0574	0.014 log10 IU/mL Standard Deviation 0.0794	-0.001 log10 IU/mL Standard Deviation 0.0436	0.046 log10 IU/mL Standard Deviation 0.0648	-0.034 log10 IU/mL Standard Deviation 0.0375	-0.023 log10 IU/mL Standard Deviation 0.0529	-0.001 log10 IU/mL Standard Deviation 0.0627	-0.041 log10 IU/mL Standard Deviation 0.0955

SECONDARY outcome

Timeframe: Baseline; Week 8

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=13 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=4 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=4 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=12 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Change From Baseline in Serum HBsAg Level at Week 8	-0.029 log10 IU/mL Standard Deviation 0.0666	0.002 log10 IU/mL Standard Deviation 0.0544	-0.035 log10 IU/mL Standard Deviation 0.0649	-0.013 log10 IU/mL Standard Deviation 0.0440	0.000 log10 IU/mL Standard Deviation 0.0442	0.006 log10 IU/mL Standard Deviation 0.0772	0.020 log10 IU/mL Standard Deviation 0.0596	0.006 log10 IU/mL Standard Deviation 0.0600	-0.021 log10 IU/mL Standard Deviation 0.0376	-0.033 log10 IU/mL Standard Deviation 0.0487	-0.013 log10 IU/mL Standard Deviation 0.0426	-0.019 log10 IU/mL Standard Deviation 0.0483

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=14 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=14 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=15 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=16 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=12 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Change From Baseline in Serum HBsAg Level at Week 12	-0.050 log10 IU/mL Standard Deviation 0.0755	0.017 log10 IU/mL Standard Deviation 0.0646	-0.004 log10 IU/mL Standard Deviation 0.0546	-0.023 log10 IU/mL Standard Deviation 0.0623	-0.031 log10 IU/mL Standard Deviation 0.0817	-0.005 log10 IU/mL Standard Deviation 0.0843	-0.021 log10 IU/mL Standard Deviation 0.0716	-0.020 log10 IU/mL Standard Deviation 0.0666	-0.023 log10 IU/mL Standard Deviation 0.0545	-0.034 log10 IU/mL Standard Deviation 0.0549	-0.010 log10 IU/mL Standard Deviation 0.0621	-0.024 log10 IU/mL Standard Deviation 0.0661

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 Participants Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=13 Participants Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=14 Participants Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=4 Participants Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=17 Participants Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=16 Participants Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=15 Participants Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 Participants Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 Participants Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 Participants Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=12 Participants Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 Participants Placebo tablet once a week for 12 weeks
Change From Baseline in Serum HBsAg Level at Week 48	-0.048 log10 IU/mL Standard Deviation 0.1054	-0.055 log10 IU/mL Standard Deviation 0.1400	-0.071 log10 IU/mL Standard Deviation 0.0857	-0.067 log10 IU/mL Standard Deviation 0.0831	-0.035 log10 IU/mL Standard Deviation 0.0923	-0.024 log10 IU/mL Standard Deviation 0.0679	-0.114 log10 IU/mL Standard Deviation 0.2169	-0.324 log10 IU/mL Standard Deviation 0.6811	-0.083 log10 IU/mL Standard Deviation 0.0858	-0.071 log10 IU/mL Standard Deviation 0.1076	-0.054 log10 IU/mL Standard Deviation 0.0715	-0.063 log10 IU/mL Standard Deviation 0.1011

Adverse Events

Vesatolimod 1 mg 4 Weeks (Cohort A)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Vesatolimod 2 mg 4 Weeks (Cohort A)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Vesatolimod 4 mg 4 Weeks (Cohort A)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo 4 Weeks (Cohort A)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vesatolimod 1 mg 8 Weeks (Cohort B)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Vesatolimod 2 mg 8 Weeks (Cohort B)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Vesatolimod 4 mg 8 Weeks (Cohort B)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo 8 Weeks (Cohort B)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Vesatolimod 1 mg 12 Weeks (Cohort C)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Vesatolimod 2 mg 12 Weeks (Cohort C)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Vesatolimod 4 mg 12 Weeks (Cohort C)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo 12 Weeks (Cohort C)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 participants at risk Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=15 participants at risk Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=16 participants at risk Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 participants at risk Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=18 participants at risk Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 participants at risk Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 participants at risk Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 participants at risk Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 participants at risk Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 participants at risk Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=14 participants at risk Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 participants at risk Placebo tablet once a week for 12 weeks
Eye disorders Cataract	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hot flush	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Vesatolimod 1 mg 4 Weeks (Cohort A) n=16 participants at risk Vesatolimod 1 mg tablet once a week for 4 weeks	Vesatolimod 2 mg 4 Weeks (Cohort A) n=15 participants at risk Vesatolimod 2 mg tablet once a week for 4 weeks	Vesatolimod 4 mg 4 Weeks (Cohort A) n=16 participants at risk Vesatolimod 4 mg tablet once a week for 4 weeks	Placebo 4 Weeks (Cohort A) n=5 participants at risk Placebo tablet once a week for 4 weeks	Vesatolimod 1 mg 8 Weeks (Cohort B) n=18 participants at risk Vesatolimod 1 mg tablet once a week for 8 weeks	Vesatolimod 2 mg 8 Weeks (Cohort B) n=17 participants at risk Vesatolimod 2 mg tablet once a week for 8 weeks	Vesatolimod 4 mg 8 Weeks (Cohort B) n=17 participants at risk Vesatolimod 4 mg tablet once a week for 8 weeks	Placebo 8 Weeks (Cohort B) n=5 participants at risk Placebo tablet once a week for 8 weeks	Vesatolimod 1 mg 12 Weeks (Cohort C) n=16 participants at risk Vesatolimod 1 mg tablet once a week for 12 weeks	Vesatolimod 2 mg 12 Weeks (Cohort C) n=17 participants at risk Vesatolimod 2 mg tablet once a week for 12 weeks	Vesatolimod 4 mg 12 Weeks (Cohort C) n=14 participants at risk Vesatolimod 4 mg tablet once a week for 12 weeks	Placebo 12 Weeks (Cohort C) n=6 participants at risk Placebo tablet once a week for 12 weeks
Vascular disorders Hypertension	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Haematoma	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Ear swelling	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo positional	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Asthenopia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Diplopia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Dry eye	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Glaucoma	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Photophobia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Photopsia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Visual acuity reduced	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Vitreous floaters	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	17.6% 3/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth cyst	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth ulceration	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 3/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Asthenia	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	35.7% 5/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Fatigue	25.0% 4/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 3/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	18.8% 3/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 2/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.8% 2/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 4/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.8% 2/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Feeling cold	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Feeling hot	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Influenza like illness	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.8% 2/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 4/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Malaise	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Mucosal dryness	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	18.8% 3/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Thirst	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Vessel puncture site bruise	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Gingivitis	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Influenza	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Oral herpes	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Oral pustule	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Respiratory tract infection viral	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Rhinitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Root canal infection	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Amylase increased	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Blood pressure abnormal	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Lipase increased	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Weight decreased	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	14.3% 2/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 2/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.8% 2/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness postural	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 3/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 6/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.8% 2/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	23.5% 4/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 4/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	17.6% 3/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	21.4% 3/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	50.0% 3/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Mental impairment	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Parosmia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Agitation	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Initial insomnia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 2/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Irritability	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Middle insomnia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Panic attack	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Micturition frequency decreased	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Nocturia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 2/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.2% 1/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.6% 1/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.8% 2/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	11.1% 2/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Nail growth abnormal	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 1/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	12.5% 2/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 1/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/15 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/18 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.9% 1/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/16 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/17 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/14 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: Baseline up to Week 48 Safety Analysis Set included all participants who received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER