Trial Outcomes & Findings for Study of ARO-ANG3 in Adults With Mixed Dyslipidemia (NCT NCT04832971)

NCT ID: NCT04832971

Last Updated: 2025-12-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

204 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2025-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 50 mg ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 50 mg Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 100 mg Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	ARO-ANG3 100 mg/ARO-ANG3 100 mg ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.	ARO-ANG3 200mg/ARO-ANG3 200mg ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Double-Blind (DB) Treatment Period COMPLETED	48	46	47	50	0	0	0	0	0	0
Double-Blind (DB) Treatment Period NOT COMPLETED	3	5	4	1	0	0	0	0	0	0
Open-Label Extension (OLE) Period STARTED	0	0	0	0	13	36	14	39	13	41
Open-Label Extension (OLE) Period COMPLETED	0	0	0	0	5	17	3	14	6	17
Open-Label Extension (OLE) Period NOT COMPLETED	0	0	0	0	8	19	11	25	7	24
Double-Blind (DB) Treatment Period STARTED	51	51	51	51	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 50 mg ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 50 mg Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 100 mg Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	ARO-ANG3 100 mg/ARO-ANG3 100 mg ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.	ARO-ANG3 200mg/ARO-ANG3 200mg ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Double-Blind (DB) Treatment Period Death	1	0	0	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Lost to Follow-up	1	1	1	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Withdrawal by Subject	1	3	3	1	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Other, Not Specified	0	1	0	0	0	0	0	0	0	0
Open-Label Extension (OLE) Period Adverse Event	0	0	0	0	0	0	2	1	1	1
Open-Label Extension (OLE) Period Death	0	0	0	0	0	0	0	1	0	0
Open-Label Extension (OLE) Period Lost to Follow-up	0	0	0	0	0	0	1	1	0	0
Open-Label Extension (OLE) Period Study Terminated by Sponsor	0	0	0	0	7	18	7	19	4	19
Open-Label Extension (OLE) Period Withdrawal by Subject	0	0	0	0	1	1	0	2	2	3
Open-Label Extension (OLE) Period Other, Not Specified	0	0	0	0	0	0	1	1	0	1

Baseline Characteristics

Study of ARO-ANG3 in Adults With Mixed Dyslipidemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=51 Participants Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Total n=204 Participants Total of all reporting groups
Age, Continuous	60.2 years STANDARD_DEVIATION 11.30 • n=3 Participants	60.4 years STANDARD_DEVIATION 12.68 • n=3 Participants	60.0 years STANDARD_DEVIATION 9.89 • n=6 Participants	61.5 years STANDARD_DEVIATION 12.53 • n=24 Participants	60.5 years STANDARD_DEVIATION 11.58 • n=15 Participants
Sex: Female, Male Female	24 Participants n=3 Participants	25 Participants n=3 Participants	22 Participants n=6 Participants	24 Participants n=24 Participants	95 Participants n=15 Participants
Sex: Female, Male Male	27 Participants n=3 Participants	26 Participants n=3 Participants	29 Participants n=6 Participants	27 Participants n=24 Participants	109 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=3 Participants	12 Participants n=3 Participants	18 Participants n=6 Participants	13 Participants n=24 Participants	55 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=3 Participants	39 Participants n=3 Participants	33 Participants n=6 Participants	38 Participants n=24 Participants	149 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants
Race/Ethnicity, Customized White	48 Participants n=3 Participants	49 Participants n=3 Participants	49 Participants n=6 Participants	49 Participants n=24 Participants	195 Participants n=15 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=24 Participants	3 Participants n=15 Participants
Race/Ethnicity, Customized Asian	1 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	1 Participants n=24 Participants	3 Participants n=15 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	1 Participants n=15 Participants
Race/Ethnicity, Customized Other	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	1 Participants n=24 Participants	2 Participants n=15 Participants
Mean Triglycerides (TG) at Baseline	235.15 mg/dL STANDARD_DEVIATION 86.117 • n=3 Participants	242.47 mg/dL STANDARD_DEVIATION 79.864 • n=3 Participants	246.71 mg/dL STANDARD_DEVIATION 97.996 • n=6 Participants	259.97 mg/dL STANDARD_DEVIATION 93.320 • n=24 Participants	246.08 mg/dL STANDARD_DEVIATION 89.386 • n=15 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set: All randomized participants who received at least 1 dose of investigational product (IP) during the study period, analyzed according to the treatment assigned at randomization.Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=47 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=49 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting TG at Week 24	-43.67 percentage change Standard Error 3.770	-49.01 percentage change Standard Error 3.777	-55.57 percentage change Standard Error 3.726	—	—	7.55 percentage change Standard Error 3.774

SECONDARY outcome

Timeframe: Baseline, up to Week 36 (double-blind treatment period)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting TG Over Time Week 8	-41.01 percentage change Standard Error 4.217	-47.73 percentage change Standard Error 4.250	-52.55 percentage change Standard Error 4.257	—	—	13.58 percentage change Standard Error 4.188
Percent Change From Baseline in Fasting TG Over Time Week 12	-42.79 percentage change Standard Error 4.269	-41.71 percentage change Standard Error 4.274	-49.84 percentage change Standard Error 4.183	—	—	2.17 percentage change Standard Error 4.305
Percent Change From Baseline in Fasting TG Over Time Week 16	-48.48 percentage change Standard Error 6.947	-51.99 percentage change Standard Error 6.942	-58.73 percentage change Standard Error 6.820	—	—	17.18 percentage change Standard Error 6.952
Percent Change From Baseline in Fasting TG Over Time Week 20	-48.70 percentage change Standard Error 5.928	-52.73 percentage change Standard Error 5.942	-57.97 percentage change Standard Error 5.790	—	—	11.54 percentage change Standard Error 5.930
Percent Change From Baseline in Fasting TG Over Time Week 24	-43.67 percentage change Standard Error 3.770	-49.01 percentage change Standard Error 3.777	-55.57 percentage change Standard Error 3.726	—	—	7.55 percentage change Standard Error 3.774
Percent Change From Baseline in Fasting TG Over Time Week 28	-41.38 percentage change Standard Error 3.966	-43.95 percentage change Standard Error 4.039	-54.39 percentage change Standard Error 3.920	—	—	7.24 percentage change Standard Error 3.950
Percent Change From Baseline in Fasting TG Over Time Week 36	-34.49 percentage change Standard Error 3.809	-38.33 percentage change Standard Error 3.850	-51.63 percentage change Standard Error 3.750	—	—	-0.43 percentage change Standard Error 3.798
Percent Change From Baseline in Fasting TG Over Time Week 4	-41.52 percentage change Standard Error 3.604	-52.22 percentage change Standard Error 3.658	-56.21 percentage change Standard Error 3.619	—	—	7.00 percentage change Standard Error 3.583

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=47 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=49 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24	-25.1 percentage change Standard Error 3.31	-24.6 percentage change Standard Error 3.31	-32.2 percentage change Standard Error 3.26	—	—	4.2 percentage change Standard Error 3.31

SECONDARY outcome

Timeframe: Baseline, up to Week 36 (double-blind treatment period)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 4	-23.5 percentage change Standard Error 2.52	-25.3 percentage change Standard Error 2.55	-32.9 percentage change Standard Error 2.50	—	—	5.2 percentage change Standard Error 2.51
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 8	-24.4 percentage change Standard Error 3.04	-22.8 percentage change Standard Error 3.04	-30.3 percentage change Standard Error 3.02	—	—	3.7 percentage change Standard Error 3.02
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 12	-22.8 percentage change Standard Error 3.04	-18.4 percentage change Standard Error 3.04	-28.1 percentage change Standard Error 2.97	—	—	3.4 percentage change Standard Error 3.06
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 16	-26.8 percentage change Standard Error 2.86	-28.3 percentage change Standard Error 2.85	-37.0 percentage change Standard Error 2.81	—	—	2.5 percentage change Standard Error 2.86
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 20	-28.1 percentage change Standard Error 2.70	-26.5 percentage change Standard Error 2.69	-34.1 percentage change Standard Error 2.64	—	—	0.8 percentage change Standard Error 2.71
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 24	-25.1 percentage change Standard Error 3.31	-24.6 percentage change Standard Error 3.31	-32.2 percentage change Standard Error 3.26	—	—	4.2 percentage change Standard Error 3.31
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 28	-23.1 percentage change Standard Error 3.01	-22.3 percentage change Standard Error 3.04	-30.0 percentage change Standard Error 2.96	—	—	1.2 percentage change Standard Error 3.00
Percent Change From Baseline in Fasting Non-HDL-C Over Time Week 36	-20.2 percentage change Standard Error 3.21	-17.3 percentage change Standard Error 3.23	-24.1 percentage change Standard Error 3.14	—	—	-1.5 percentage change Standard Error 3.19

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=46 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=46 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=48 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=46 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24	-16.40 percentage change Standard Error 2.835	-12.91 percentage change Standard Error 2.805	-19.64 percentage change Standard Error 2.788	—	—	2.27 percentage change Standard Error 2.807

SECONDARY outcome

Timeframe: Baseline, up to Week 36 (double-blind treatment period)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Total ApoB Over Time Week 4	-14.00 percentage change Standard Error 2.116	-11.71 percentage change Standard Error 2.093	-18.47 percentage change Standard Error 2.105	—	—	2.57 percentage change Standard Error 2.074
Percent Change From Baseline in Fasting Total ApoB Over Time Week 8	-15.85 percentage change Standard Error 2.553	-10.66 percentage change Standard Error 2.525	-15.05 percentage change Standard Error 2.556	—	—	1.51 percentage change Standard Error 2.518
Percent Change From Baseline in Fasting Total ApoB Over Time Week 12	-14.96 percentage change Standard Error 2.653	-7.69 percentage change Standard Error 2.617	-15.10 percentage change Standard Error 2.606	—	—	2.26 percentage change Standard Error 2.656
Percent Change From Baseline in Fasting Total ApoB Over Time Week 16	-15.72 percentage change Standard Error 2.543	-14.33 percentage change Standard Error 2.513	-21.66 percentage change Standard Error 2.509	—	—	-1.36 percentage change Standard Error 2.524
Percent Change From Baseline in Fasting Total ApoB Over Time Week 20	-17.99 percentage change Standard Error 2.370	-14.52 percentage change Standard Error 2.329	-18.58 percentage change Standard Error 2.326	—	—	-0.28 percentage change Standard Error 2.350
Percent Change From Baseline in Fasting Total ApoB Over Time Week 24	-16.40 percentage change Standard Error 2.835	-12.91 percentage change Standard Error 2.805	-19.64 percentage change Standard Error 2.788	—	—	2.27 percentage change Standard Error 2.807
Percent Change From Baseline in Fasting Total ApoB Over Time Week 28	-15.39 percentage change Standard Error 2.725	-12.47 percentage change Standard Error 2.703	-17.03 percentage change Standard Error 2.680	—	—	0.51 percentage change Standard Error 2.688
Percent Change From Baseline in Fasting Total ApoB Over Time Week 36	-12.85 percentage change Standard Error 2.801	-9.07 percentage change Standard Error 2.791	-13.21 percentage change Standard Error 2.756	—	—	-2.30 percentage change Standard Error 2.777

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=47 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=49 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24	-11.0 percentage change Standard Error 4.58	-4.3 percentage change Standard Error 4.56	-15.1 percentage change Standard Error 4.51	—	—	5.0 percentage change Standard Error 4.53

SECONDARY outcome

Timeframe: Baseline, up to Week 36 (double-blind treatment period)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 4	-8.3 percentage change Standard Error 4.03	-3.4 percentage change Standard Error 4.02	-13.7 percentage change Standard Error 3.98	—	—	5.1 percentage change Standard Error 3.95
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 8	-10.1 percentage change Standard Error 4.85	-0.7 percentage change Standard Error 4.83	-10.8 percentage change Standard Error 4.81	—	—	3.7 percentage change Standard Error 4.78
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 12	-7.6 percentage change Standard Error 7.36	7.9 percentage change Standard Error 7.34	-12.1 percentage change Standard Error 7.23	—	—	7.7 percentage change Standard Error 7.31
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 16	-9.5 percentage change Standard Error 4.56	-7.4 percentage change Standard Error 4.52	-19.5 percentage change Standard Error 4.48	—	—	3.6 percentage change Standard Error 4.51
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 20	-12.2 percentage change Standard Error 4.31	-6.9 percentage change Standard Error 4.28	-15.3 percentage change Standard Error 4.22	—	—	1.8 percentage change Standard Error 4.26
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 24	-11.0 percentage change Standard Error 4.58	-4.3 percentage change Standard Error 4.56	-15.1 percentage change Standard Error 4.51	—	—	5.0 percentage change Standard Error 4.53
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 28	-9.1 percentage change Standard Error 4.75	-2.4 percentage change Standard Error 4.74	-11.3 percentage change Standard Error 4.66	—	—	0.2 percentage change Standard Error 4.67
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Week 36	-8.9 percentage change Standard Error 5.81	3.7 percentage change Standard Error 5.82	-4.4 percentage change Standard Error 5.71	—	—	3.1 percentage change Standard Error 5.75

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=46 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=47 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=49 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24	-53.02 percentage change Standard Error 2.829	-68.52 percentage change Standard Error 2.807	-72.45 percentage change Standard Error 2.761	—	—	1.24 percentage change Standard Error 2.801

SECONDARY outcome

Timeframe: Baseline, up to Week 36 (double-blind treatment period)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in ANGPTL3 Over Time Week 4	-62.11 percentage change Standard Error 2.388	-75.25 percentage change Standard Error 2.401	-79.15 percentage change Standard Error 2.365	—	—	5.54 percentage change Standard Error 2.353
Percent Change From Baseline in ANGPTL3 Over Time Week 8	-56.09 percentage change Standard Error 3.074	-69.01 percentage change Standard Error 3.066	-73.47 percentage change Standard Error 3.045	—	—	2.97 percentage change Standard Error 3.023
Percent Change From Baseline in ANGPTL3 Over Time Week 12	-47.72 percentage change Standard Error 3.635	-63.17 percentage change Standard Error 3.608	-66.62 percentage change Standard Error 3.542	—	—	7.38 percentage change Standard Error 3.599
Percent Change From Baseline in ANGPTL3 Over Time Week 16	-63.73 percentage change Standard Error 2.400	-75.61 percentage change Standard Error 2.379	-80.52 percentage change Standard Error 2.345	—	—	8.48 percentage change Standard Error 2.379
Percent Change From Baseline in ANGPTL3 Over Time Week 20	-60.50 percentage change Standard Error 2.360	-73.10 percentage change Standard Error 2.347	-76.25 percentage change Standard Error 2.299	—	—	4.35 percentage change Standard Error 2.338
Percent Change From Baseline in ANGPTL3 Over Time Week 24	-53.02 percentage change Standard Error 2.829	-68.52 percentage change Standard Error 2.807	-72.45 percentage change Standard Error 2.761	—	—	1.24 percentage change Standard Error 2.801
Percent Change From Baseline in ANGPTL3 Over Time Week 28	-49.57 percentage change Standard Error 2.920	-61.43 percentage change Standard Error 2.921	-68.19 percentage change Standard Error 2.852	—	—	5.18 percentage change Standard Error 2.879
Percent Change From Baseline in ANGPTL3 Over Time Week 36	-41.70 percentage change Standard Error 3.158	-53.41 percentage change Standard Error 3.155	-59.85 percentage change Standard Error 3.066	—	—	3.73 percentage change Standard Error 3.110

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=47 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=49 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=47 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24	-9.0 percentage change Standard Error 2.94	-18.5 percentage change Standard Error 2.96	-21.5 percentage change Standard Error 2.89	—	—	3.1 percentage change Standard Error 2.91

SECONDARY outcome

Timeframe: Baseline, up to Week 36 (double-blind treatment period)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=51 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting HDL-C Over Time Week 4	-13.9 percentage change Standard Error 2.63	-25.5 percentage change Standard Error 2.68	-24.8 percentage change Standard Error 2.61	—	—	-0.3 percentage change Standard Error 2.59
Percent Change From Baseline in Fasting HDL-C Over Time Week 8	-14.5 percentage change Standard Error 2.71	-25.0 percentage change Standard Error 2.74	-25.8 percentage change Standard Error 2.69	—	—	0.4 percentage change Standard Error 2.67
Percent Change From Baseline in Fasting HDL-C Over Time Week 12	-7.0 percentage change Standard Error 3.11	-18.7 percentage change Standard Error 3.14	-18.2 percentage change Standard Error 3.05	—	—	2.0 percentage change Standard Error 3.10
Percent Change From Baseline in Fasting HDL-C Over Time Week 16	-15.8 percentage change Standard Error 3.02	-28.5 percentage change Standard Error 3.04	-30.2 percentage change Standard Error 2.96	—	—	2.1 percentage change Standard Error 2.99
Percent Change From Baseline in Fasting HDL-C Over Time Week 20	-11.3 percentage change Standard Error 2.92	-25.1 percentage change Standard Error 2.94	-27.1 percentage change Standard Error 2.86	—	—	3.4 percentage change Standard Error 2.89
Percent Change From Baseline in Fasting HDL-C Over Time Week 24	-9.0 percentage change Standard Error 2.94	-18.5 percentage change Standard Error 2.96	-21.5 percentage change Standard Error 2.89	—	—	3.1 percentage change Standard Error 2.91
Percent Change From Baseline in Fasting HDL-C Over Time Week 28	-5.5 percentage change Standard Error 2.82	-14.7 percentage change Standard Error 2.87	-18.6 percentage change Standard Error 2.77	—	—	3.0 percentage change Standard Error 2.78
Percent Change From Baseline in Fasting HDL-C Over Time Week 36	-1.4 percentage change Standard Error 2.82	-13.7 percentage change Standard Error 2.86	-9.4 percentage change Standard Error 2.75	—	—	6.4 percentage change Standard Error 2.78

SECONDARY outcome

Timeframe: Baseline, Day 1: pre-dose, 15 minutes, 1, 3, 6 hours post-dose; Day 2: 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose (double-blind treatment period)

Population: Full PK Analysis Set: All participants who received at least 1 dose of active study drug and had at least 1 PK concentration data value. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=21 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=18 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=16 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Day 1, Pre-Dose	2.6685 ng/mL Standard Deviation 12.22871	0.0000 ng/mL Standard Deviation 0.00000	—	—	—	0.0000 ng/mL Standard Deviation 0.00000
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Day 1, 15 Minutes Post-Dose	63.5267 ng/mL Standard Deviation 55.85108	154.7823 ng/mL Standard Deviation 129.43190	—	—	—	57.6941 ng/mL Standard Deviation 28.05778
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Day 1, 1 Hour Post-Dose	130.3387 ng/mL Standard Deviation 81.73501	221.5979 ng/mL Standard Deviation 105.15447	—	—	—	75.3752 ng/mL Standard Deviation 31.39048
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Day 1, 3 Hours Post-Dose	143.7746 ng/mL Standard Deviation 79.62215	259.2799 ng/mL Standard Deviation 144.46149	—	—	—	77.9834 ng/mL Standard Deviation 34.90982
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Day 1, 6 Hours Post-Dose	152.0097 ng/mL Standard Deviation 91.30854	280.0843 ng/mL Standard Deviation 153.62465	—	—	—	83.9751 ng/mL Standard Deviation 53.53021
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Day 2, 24 Hours Post-Dose	33.3047 ng/mL Standard Deviation 16.31049	77.9982 ng/mL Standard Deviation 31.94202	—	—	—	13.3369 ng/mL Standard Deviation 8.85893
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Week 12, Pre-Dose	0.0653 ng/mL Standard Deviation 0.27695	1.9366 ng/mL Standard Deviation 7.74650	—	—	—	0.0000 ng/mL Standard Deviation 0.00000
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Week 12, 15 Minutes Post-Dose	68.3054 ng/mL Standard Deviation 52.28977	134.0610 ng/mL Standard Deviation 138.22698	—	—	—	54.2741 ng/mL Standard Deviation 43.95835
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Week 12, 1 Hour Post-Dose	130.2505 ng/mL Standard Deviation 52.66507	247.9728 ng/mL Standard Deviation 112.83368	—	—	—	76.2131 ng/mL Standard Deviation 34.49650
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Week 12, 3 Hours Post-Dose	152.0302 ng/mL Standard Deviation 78.31595	304.2006 ng/mL Standard Deviation 178.69258	—	—	—	78.2496 ng/mL Standard Deviation 36.47898
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Week 12, 6 Hours Post-Dose	154.3280 ng/mL Standard Deviation 71.93043	312.6397 ng/mL Standard Deviation 174.86753	—	—	—	87.6919 ng/mL Standard Deviation 37.30155
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period Week 12, 24 Hours Post-Dose	36.2506 ng/mL Standard Deviation 18.33432	103.1401 ng/mL Standard Deviation 60.85616	—	—	—	15.3604 ng/mL Standard Deviation 13.03807

SECONDARY outcome

Timeframe: From first dose of IP up to Week 24

Population: Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.

TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=50 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=52 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24 All TEAEs (Including Serious)	37 Participants	29 Participants	39 Participants	—	—	30 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24 Serious TEAEs	3 Participants	0 Participants	1 Participants	—	—	3 Participants

SECONDARY outcome

Timeframe: up to Week 36 (double-blind treatment period)

Population: Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.

Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=50 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=51 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=52 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=51 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period All Treatment-Emergent Adverse Events (TEAEs)	40 Participants	34 Participants	42 Participants	—	—	35 Participants
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period Treatment-related TEAEs	12 Participants	8 Participants	12 Participants	—	—	8 Participants
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period Serious TEAEs	5 Participants	0 Participants	1 Participants	—	—	4 Participants
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period TEAEs leading to study drug discontinuation	0 Participants	1 Participants	0 Participants	—	—	2 Participants
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period Deaths	0 Participants	0 Participants	0 Participants	—	—	1 Participants
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period Local Injection Site Reactions (LISR)	0 Participants	3 Participants	2 Participants	—	—	1 Participants

SECONDARY outcome

Timeframe: From first dose of study drug in the OLE up to Month 24 (open-label extension)

Population: Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period All Treatment-Emergent Adverse Events (TEAEs)	27 Participants	13 Participants	30 Participants	10 Participants	31 Participants	10 Participants
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period Treatment-related TEAEs	8 Participants	4 Participants	6 Participants	0 Participants	6 Participants	2 Participants
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period Serious TEAEs	4 Participants	2 Participants	5 Participants	2 Participants	5 Participants	3 Participants
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period TEAEs leading to study drug discontinuation	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period Deaths	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Baseline/OLE Day 1	-34.78 percentage change Standard Error 3.941	-2.09 percentage change Standard Error 13.925	-39.64 percentage change Standard Error 3.357	7.87 percentage change Standard Error 12.061	-51.88 percentage change Standard Error 2.612	-10.02 percentage change Standard Error 8.711
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 1	-45.32 percentage change Standard Error 3.994	-50.45 percentage change Standard Error 7.323	-52.86 percentage change Standard Error 3.051	-49.57 percentage change Standard Error 5.990	-62.76 percentage change Standard Error 2.262	-43.74 percentage change Standard Error 5.555
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 2	-45.78 percentage change Standard Error 4.449	-48.96 percentage change Standard Error 7.586	-51.51 percentage change Standard Error 2.712	-48.98 percentage change Standard Error 6.568	-58.66 percentage change Standard Error 2.135	-47.14 percentage change Standard Error 4.687
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 3	-42.51 percentage change Standard Error 3.294	-42.05 percentage change Standard Error 8.623	-48.07 percentage change Standard Error 3.255	-40.73 percentage change Standard Error 8.993	-56.59 percentage change Standard Error 2.225	-40.67 percentage change Standard Error 5.792
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 6	-48.67 percentage change Standard Error 4.081	-48.62 percentage change Standard Error 7.597	-46.81 percentage change Standard Error 3.828	-46.34 percentage change Standard Error 8.818	-57.14 percentage change Standard Error 2.697	-45.81 percentage change Standard Error 7.065
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 12	-47.10 percentage change Standard Error 3.546	-52.40 percentage change Standard Error 6.578	-50.56 percentage change Standard Error 4.288	-49.06 percentage change Standard Error 3.275	-58.36 percentage change Standard Error 2.110	-40.57 percentage change Standard Error 9.384
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 15	-47.33 percentage change Standard Error 3.969	-58.81 percentage change Standard Error 4.310	-56.23 percentage change Standard Error 2.968	-44.56 percentage change Standard Error 4.440	-53.57 percentage change Standard Error 4.055	-47.40 percentage change Standard Error 6.442
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 18	-48.48 percentage change Standard Error 3.041	-55.29 percentage change Standard Error 5.170	-55.11 percentage change Standard Error 3.039	-49.25 percentage change Standard Error 4.860	-51.71 percentage change Standard Error 4.761	-48.07 percentage change Standard Error 6.892
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 21	-45.95 percentage change Standard Error 3.609	-58.42 percentage change Standard Error 3.043	-55.23 percentage change Standard Error 3.101	-49.30 percentage change Standard Error 4.388	-47.42 percentage change Standard Error 6.810	-41.86 percentage change Standard Error 9.334
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 24	-53.83 percentage change Standard Error 3.490	-61.61 percentage change Standard Error 8.343	-56.65 percentage change Standard Error 3.545	-51.88 percentage change Standard Error 3.705	-58.96 percentage change Standard Error 3.563	-48.23 percentage change Standard Error 11.315

SECONDARY outcome

Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 3	-20.71 percentage change Standard Error 3.770	-19.61 percentage change Standard Error 4.659	-22.97 percentage change Standard Error 3.462	-25.19 percentage change Standard Error 4.215	-26.68 percentage change Standard Error 3.107	-14.32 percentage change Standard Error 6.774
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 6	-22.11 percentage change Standard Error 4.372	-26.53 percentage change Standard Error 4.347	-24.38 percentage change Standard Error 3.392	-30.83 percentage change Standard Error 4.832	-27.84 percentage change Standard Error 3.414	-10.42 percentage change Standard Error 7.330
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 12	-22.82 percentage change Standard Error 4.267	-24.42 percentage change Standard Error 7.159	-30.48 percentage change Standard Error 3.626	-28.60 percentage change Standard Error 3.545	-30.08 percentage change Standard Error 2.731	-13.72 percentage change Standard Error 9.131
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 15	-24.01 percentage change Standard Error 4.257	-25.66 percentage change Standard Error 3.442	-31.53 percentage change Standard Error 3.040	-25.86 percentage change Standard Error 4.405	-27.73 percentage change Standard Error 3.387	-13.02 percentage change Standard Error 13.661
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 18	-23.26 percentage change Standard Error 3.579	-25.34 percentage change Standard Error 4.315	-33.90 percentage change Standard Error 3.422	-29.09 percentage change Standard Error 4.005	-27.88 percentage change Standard Error 3.495	-23.39 percentage change Standard Error 6.010
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 21	-25.07 percentage change Standard Error 3.492	-34.23 percentage change Standard Error 3.783	-30.46 percentage change Standard Error 2.642	-28.66 percentage change Standard Error 4.590	-25.75 percentage change Standard Error 3.735	-13.13 percentage change Standard Error 14.219
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 24	-27.52 percentage change Standard Error 5.126	-37.23 percentage change Standard Error 3.633	-31.95 percentage change Standard Error 4.492	-24.24 percentage change Standard Error 9.558	-30.82 percentage change Standard Error 4.407	-32.24 percentage change Standard Error 14.568
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 1	-22.99 percentage change Standard Error 3.544	-25.80 percentage change Standard Error 4.039	-25.23 percentage change Standard Error 3.912	-28.13 percentage change Standard Error 3.930	-33.41 percentage change Standard Error 3.158	-14.79 percentage change Standard Error 6.493
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 2	-25.54 percentage change Standard Error 3.730	-22.32 percentage change Standard Error 5.340	-22.98 percentage change Standard Error 3.151	-28.43 percentage change Standard Error 4.168	-30.35 percentage change Standard Error 3.013	-14.70 percentage change Standard Error 5.087
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Baseline/OLE Day 1	-19.95 percentage change Standard Error 3.532	-5.02 percentage change Standard Error 5.171	-16.02 percentage change Standard Error 3.824	-2.53 percentage change Standard Error 3.750	-23.12 percentage change Standard Error 3.116	6.70 percentage change Standard Error 13.049

SECONDARY outcome

Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Baseline/OLE Day 1	-13.49 percentage change Standard Error 3.086	-10.22 percentage change Standard Error 4.678	-7.48 percentage change Standard Error 2.924	-3.88 percentage change Standard Error 3.080	-11.77 percentage change Standard Error 3.309	6.57 percentage change Standard Error 8.959
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 1	—	-1.65 percentage change Standard Error NA n=1	-4.45 percentage change Standard Error NA n=1	—	-21.63 percentage change Standard Error NA n=1	6.82 percentage change Standard Error NA n=1
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 2	-21.00 percentage change Standard Error 6.460	-3.56 percentage change Standard Error 6.243	-7.93 percentage change Standard Error 5.968	-11.37 percentage change Standard Error 16.839	-7.58 percentage change Standard Error 6.338	0.31 percentage change Standard Error 8.213
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 3	-13.01 percentage change Standard Error 7.131	-0.30 percentage change Standard Error 3.518	-7.09 percentage change Standard Error 5.090	-13.13 percentage change Standard Error 4.275	-8.34 percentage change Standard Error 3.722	-5.48 percentage change Standard Error 13.745
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 6	-13.89 percentage change Standard Error 3.645	-13.84 percentage change Standard Error 3.803	-11.91 percentage change Standard Error 3.517	-18.14 percentage change Standard Error 2.810	-14.04 percentage change Standard Error 3.504	-1.23 percentage change Standard Error 7.644
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 12	-12.63 percentage change Standard Error 3.662	-13.78 percentage change Standard Error 6.382	-15.14 percentage change Standard Error 3.520	-13.87 percentage change Standard Error 2.996	-15.90 percentage change Standard Error 2.835	-3.46 percentage change Standard Error 9.733
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 15	-12.73 percentage change Standard Error 3.587	-13.40 percentage change Standard Error 3.056	-16.23 percentage change Standard Error 2.661	-11.27 percentage change Standard Error 4.524	-13.05 percentage change Standard Error 3.530	-8.08 percentage change Standard Error 9.722
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 18	-13.83 percentage change Standard Error 3.624	-14.12 percentage change Standard Error 3.655	-19.88 percentage change Standard Error 2.991	-13.63 percentage change Standard Error 3.819	-13.92 percentage change Standard Error 3.741	-14.34 percentage change Standard Error 5.296
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 21	-13.42 percentage change Standard Error 3.462	-21.03 percentage change Standard Error 3.791	-15.03 percentage change Standard Error 2.910	-15.70 percentage change Standard Error 4.187	-11.85 percentage change Standard Error 3.789	0.08 percentage change Standard Error 10.835
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 24	-14.39 percentage change Standard Error 5.371	-24.76 percentage change Standard Error 4.680	-16.73 percentage change Standard Error 4.236	-10.27 percentage change Standard Error 8.790	-18.04 percentage change Standard Error 4.441	-6.57 percentage change Standard Error 11.292

SECONDARY outcome

Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Baseline/OLE Day 1	-7.68 percentage change Standard Error 4.934	-1.59 percentage change Standard Error 8.079	4.59 percentage change Standard Error 7.053	4.13 percentage change Standard Error 5.905	-2.82 percentage change Standard Error 5.633	16.61 percentage change Standard Error 13.866
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 1	-4.90 percentage change Standard Error 5.203	-7.43 percentage change Standard Error 5.762	-0.07 percentage change Standard Error 7.654	3.74 percentage change Standard Error 16.591	-10.01 percentage change Standard Error 4.929	6.61 percentage change Standard Error 8.960
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 2	-10.81 percentage change Standard Error 5.105	-3.40 percentage change Standard Error 7.119	7.38 percentage change Standard Error 12.473	3.50 percentage change Standard Error 20.049	-10.08 percentage change Standard Error 4.989	5.75 percentage change Standard Error 6.546
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 3	-2.69 percentage change Standard Error 5.570	-2.47 percentage change Standard Error 7.839	1.94 percentage change Standard Error 7.628	5.74 percentage change Standard Error 20.327	-1.59 percentage change Standard Error 6.358	3.79 percentage change Standard Error 8.934
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 6	-2.03 percentage change Standard Error 6.503	-10.68 percentage change Standard Error 5.700	-9.92 percentage change Standard Error 4.137	3.32 percentage change Standard Error 20.431	-2.80 percentage change Standard Error 6.230	16.09 percentage change Standard Error 11.331
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 12	-2.77 percentage change Standard Error 6.090	-4.64 percentage change Standard Error 9.376	-8.25 percentage change Standard Error 7.573	4.05 percentage change Standard Error 18.896	-6.97 percentage change Standard Error 4.466	6.95 percentage change Standard Error 14.056
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 15	-7.84 percentage change Standard Error 6.363	-6.14 percentage change Standard Error 6.380	-5.41 percentage change Standard Error 11.638	5.82 percentage change Standard Error 18.362	-7.85 percentage change Standard Error 5.264	8.54 percentage change Standard Error 17.305
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 18	-5.88 percentage change Standard Error 5.801	-4.52 percentage change Standard Error 7.677	-13.20 percentage change Standard Error 7.882	6.86 percentage change Standard Error 21.962	-8.43 percentage change Standard Error 5.346	-9.73 percentage change Standard Error 8.195
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 21	-6.14 percentage change Standard Error 5.553	-12.81 percentage change Standard Error 7.465	-4.47 percentage change Standard Error 8.744	-15.64 percentage change Standard Error 7.008	-2.16 percentage change Standard Error 5.032	9.29 percentage change Standard Error 18.925
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 24	-10.57 percentage change Standard Error 6.996	-12.81 percentage change Standard Error 9.496	-13.83 percentage change Standard Error 5.902	-9.58 percentage change Standard Error 14.506	-6.18 percentage change Standard Error 6.423	-7.17 percentage change Standard Error 22.117

SECONDARY outcome

Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Baseline/OLE Day 1	-41.57 percentage change Standard Error 4.417	4.47 percentage change Standard Error 7.595	-56.81 percentage change Standard Error 3.166	0.79 percentage change Standard Error 4.664	-59.24 percentage change Standard Error 3.551	3.41 percentage change Standard Error 5.372
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 1	-65.83 percentage change Standard Error 2.836	-77.02 percentage change Standard Error 2.699	-76.03 percentage change Standard Error 1.982	-74.62 percentage change Standard Error 3.753	-77.96 percentage change Standard Error 2.273	-59.55 percentage change Standard Error 3.490
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 2	-60.01 percentage change Standard Error 3.812	-67.75 percentage change Standard Error 4.771	-71.21 percentage change Standard Error 2.367	-70.19 percentage change Standard Error 3.928	-74.59 percentage change Standard Error 2.775	-53.85 percentage change Standard Error 3.393
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 3	-48.56 percentage change Standard Error 6.842	-61.65 percentage change Standard Error 4.510	-65.54 percentage change Standard Error 3.020	-64.79 percentage change Standard Error 5.478	-68.91 percentage change Standard Error 3.310	-43.36 percentage change Standard Error 5.072
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 6	-54.18 percentage change Standard Error 4.076	-67.23 percentage change Standard Error 4.070	-68.85 percentage change Standard Error 2.867	-69.38 percentage change Standard Error 3.736	-67.04 percentage change Standard Error 3.743	-49.22 percentage change Standard Error 5.280
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 12	-55.20 percentage change Standard Error 4.666	-71.03 percentage change Standard Error 4.370	-69.32 percentage change Standard Error 3.691	-63.23 percentage change Standard Error 5.801	-62.00 percentage change Standard Error 4.122	-55.48 percentage change Standard Error 5.056
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 15	-52.97 percentage change Standard Error 4.560	-65.80 percentage change Standard Error 4.669	-65.28 percentage change Standard Error 6.196	-64.57 percentage change Standard Error 3.909	-55.73 percentage change Standard Error 5.734	-53.01 percentage change Standard Error 3.998
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 18	-39.57 percentage change Standard Error 5.638	-65.71 percentage change Standard Error 4.877	-65.97 percentage change Standard Error 3.280	-61.38 percentage change Standard Error 4.943	-55.31 percentage change Standard Error 4.725	-36.82 percentage change Standard Error 9.076
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 21	-43.45 percentage change Standard Error 5.176	-63.26 percentage change Standard Error 4.176	-64.68 percentage change Standard Error 3.414	-58.10 percentage change Standard Error 4.837	-55.43 percentage change Standard Error 4.784	-40.12 percentage change Standard Error 5.814
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 24	-50.18 percentage change Standard Error 6.570	-48.46 percentage change Standard Error 14.321	-62.95 percentage change Standard Error 4.439	-61.52 percentage change Standard Error 3.012	-63.89 percentage change Standard Error 4.009	-44.08 percentage change Standard Error 10.028

SECONDARY outcome

Timeframe: Baseline, OLE Baseline, Months 1-24 (open-label extension)

Population: Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.

Outcome measures

Outcome measures
Measure	ARO-ANG3 50 mg n=36 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 100 mg n=14 Participants ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	ARO-ANG3 200 mg n=39 Participants ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 Participants Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 200 mg/ARO-ANG3 200 mg n=41 Participants ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=13 Participants ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 6	-3.95 percentage change Standard Error 4.247	-21.38 percentage change Standard Error 6.028	-26.54 percentage change Standard Error 3.486	-13.75 percentage change Standard Error 6.207	-20.43 percentage change Standard Error 4.082	-8.26 percentage change Standard Error 6.279
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 12	-16.58 percentage change Standard Error 3.672	-22.23 percentage change Standard Error 5.893	-26.51 percentage change Standard Error 3.816	-5.47 percentage change Standard Error 5.504	-18.32 percentage change Standard Error 4.314	-13.83 percentage change Standard Error 7.363
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 15	-12.02 percentage change Standard Error 5.116	-19.76 percentage change Standard Error 5.356	-29.44 percentage change Standard Error 3.110	-14.07 percentage change Standard Error 5.004	-15.04 percentage change Standard Error 4.116	-9.01 percentage change Standard Error 6.448
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 18	-4.80 percentage change Standard Error 5.980	-21.60 percentage change Standard Error 5.268	-28.55 percentage change Standard Error 3.462	-11.86 percentage change Standard Error 4.787	-16.39 percentage change Standard Error 4.648	-10.53 percentage change Standard Error 6.499
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 21	-12.48 percentage change Standard Error 3.816	-22.77 percentage change Standard Error 4.713	-26.12 percentage change Standard Error 3.535	-16.68 percentage change Standard Error 2.024	-17.82 percentage change Standard Error 3.788	-3.87 percentage change Standard Error 6.823
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 24	-11.66 percentage change Standard Error 5.293	-20.28 percentage change Standard Error 15.397	-27.31 percentage change Standard Error 4.225	-16.01 percentage change Standard Error 3.759	-24.10 percentage change Standard Error 5.009	-8.97 percentage change Standard Error 10.168
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Baseline/OLE Day 1	1.67 percentage change Standard Error 3.360	7.70 percentage change Standard Error 5.318	-12.88 percentage change Standard Error 3.147	4.80 percentage change Standard Error 4.562	-11.26 percentage change Standard Error 3.771	13.70 percentage change Standard Error 6.036
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 1	-12.31 percentage change Standard Error 3.791	-26.62 percentage change Standard Error 4.804	-28.81 percentage change Standard Error 3.214	-14.33 percentage change Standard Error 8.371	-28.27 percentage change Standard Error 3.705	-10.68 percentage change Standard Error 8.416
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 2	-10.98 percentage change Standard Error 3.588	-19.64 percentage change Standard Error 4.846	-24.78 percentage change Standard Error 3.397	-13.48 percentage change Standard Error 7.252	-28.24 percentage change Standard Error 3.362	-9.46 percentage change Standard Error 6.308
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period Percent Change from Baseline to OLE Month 3	-9.96 percentage change Standard Error 3.318	-15.50 percentage change Standard Error 4.847	-22.29 percentage change Standard Error 3.771	-12.81 percentage change Standard Error 5.209	-19.78 percentage change Standard Error 3.504	-8.80 percentage change Standard Error 5.376

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 41 other events

Deaths: 1 deaths

ARO-ANG3 50 mg

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

ARO-ANG3 100 mg

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

ARO-ANG3 200 mg

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Placebo/ARO-ANG3 50 mg

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

ARO-ANG3 50 mg/ARO-ANG3 50 mg

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo/ARO-ANG3 100 mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

ARO-ANG3 100 mg/ARO-ANG3 100 mg

Serious events: 5 serious events

Other events: 34 other events

Deaths: 1 deaths

Placebo/ARO-ANG3 200 mg

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

ARO-ANG3 200mg/ARO-ANG3 200 mg

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=51 participants at risk Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period.	ARO-ANG3 50 mg n=50 participants at risk ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.	ARO-ANG3 100 mg n=51 participants at risk ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.	ARO-ANG3 200 mg n=52 participants at risk ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.	Placebo/ARO-ANG3 50 mg n=13 participants at risk Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=36 participants at risk ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 100 mg n=14 participants at risk Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	ARO-ANG3 100 mg/ARO-ANG3 100 mg n=39 participants at risk ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 participants at risk Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.	ARO-ANG3 200mg/ARO-ANG3 200 mg n=41 participants at risk ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Cardiac disorders Acute myocardial infarction	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Angina unstable	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Atrial fibrillation	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Bundle branch block left	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Cardiac failure	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Coronary artery stenosis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Myocardial infarction	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Silent myocardial infarction	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Inguinal hernia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Pancreatitis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Death	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Non-cardiac chest pain	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations COVID-19 pneumonia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Cellulitis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Influenza	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Pneumonia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Pyelonephritis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Sepsis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Diabetic ketosis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Dizziness	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Syncope	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Transient ischaemic attack	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Acute kidney injury	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Chronic rhinosinusitis with nasal polyps	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.

Other adverse events

Other adverse events
Measure	Placebo n=51 participants at risk Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period.	ARO-ANG3 50 mg n=50 participants at risk ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.	ARO-ANG3 100 mg n=51 participants at risk ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.	ARO-ANG3 200 mg n=52 participants at risk ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.	Placebo/ARO-ANG3 50 mg n=13 participants at risk Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	ARO-ANG3 50 mg/ARO-ANG3 50 mg n=36 participants at risk ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 100 mg n=14 participants at risk Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	ARO-ANG3 100 mg/ARO-ANG3 100 mg n=39 participants at risk ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.	Placebo/ARO-ANG3 200 mg n=13 participants at risk Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.	ARO-ANG3 200mg/ARO-ANG3 200 mg n=41 participants at risk ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Blood and lymphatic system disorders Anaemia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Angina pectoris	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Leukocytosis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Splenic cyst	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Aortic valve sclerosis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Atrial fibrillation	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Cardiac failure	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Cardiac failure congestive	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Heart failure with reduced ejection fraction	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Hypertensive heart disease	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Left ventricular dysfunction	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Mitral valve incompetence	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Myocardial ischaemia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Palpitations	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Suprventricular tachycardia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Cardiac disorders Tricuspid valve incompetence	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Ear and labyrinth disorders Ear pain	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Ear and labyrinth disorders Hypoacusis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Eye disorders Cataract	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Eye disorders Chalazion	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Eye disorders Eyelid oedema	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Eye disorders Eyelid ptosis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal distension	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain upper	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Acquired oesophageal web	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Barrett's oesophagus	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Constipation	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Defaecation urgency	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Dental caries	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Diarrhoea	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	10.3% 4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.8% 4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Dyspepsia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Dysphagia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Gastritis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Haemorrhoids	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Hiatus hernia	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Large intestine polyp	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Nausea	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Tooth impacted	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Gastrointestinal disorders Toothache	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Administration site reaction	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Asthenia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Fatigue	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Influenza like illness	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Injection site bruising	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Injection site erythema	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	11.5% 6/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.6% 6/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Injection site induration	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Injection site pain	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	10.0% 5/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	13.7% 7/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	11.1% 4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 6/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Injection site pruritus	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Malaise	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Non-cardiac chest pain	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
General disorders Peripheral swelling	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholelithiasis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Hepatobiliary disorders Hepatic cyst	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Hepatobiliary disorders Hepatic steatosis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Immune system disorders Drug hypersensitivity	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Acute sinusitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Asymptomatic bacteriuria	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Bronchitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	10.3% 4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations COVID-19	27.5% 14/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	32.0% 16/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	31.4% 16/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	34.6% 18/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	23.1% 3/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	38.9% 14/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	35.7% 5/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	33.3% 13/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	30.8% 4/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	36.6% 15/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Conjunctivitis	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Diverticulitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Ear infection	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Fungal skin infection	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Gastroenteritis	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	21.4% 3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Helicobacter gastritis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Infective exacerbation of asthma	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Influenza	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Labyrinthitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Lower respiratory tract infection	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Nasopharyngitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Pneumonia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Postoperative wound infection	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Pyuria	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Respiratory tract infection	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Sinusitis	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.8% 4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Subcutaneous abscess	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Tonsillitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Tooth abscess	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Tooth infection	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Upper respiratory tract infection	13.7% 7/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	16.0% 8/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	17.6% 9/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	21.2% 11/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	16.7% 6/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	21.4% 3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	23.1% 9/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	22.0% 9/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Urinary tract infection	9.8% 5/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	12.0% 6/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	11.8% 6/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	23.1% 12/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	11.1% 4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	10.3% 4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	19.5% 8/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Viral pharyngitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Infections and infestations Wound infection	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Arthropod bite	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Bone contusion	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Burns second degree	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Clavicle fracture	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Contusion	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Ear canal injury	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Fall	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Joint injury	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Ligament rupture	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Ligament sprain	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Limb injury	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Muscle strain	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Musculoskeletal injury	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Rib fracture	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Road traffic accident	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Skin laceration	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Tendon injury	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Wrist fracture	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Amylase increased	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Bacterial test positive	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Blood creatine phosphokinase increased	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Blood glucose increased	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Blood potassium decreased	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations C-reactive protein increased	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Cardiac murmur	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Gamma-glutamyltransferase increased	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Glycosylated haemoglobin increased	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.0% 4/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	11.1% 4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations High density lipoprotein decreased	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Lipase increased	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Low density lipoprotein increased	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Troponin increased	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations Urine analysis abnormal	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Investigations White blood cells urine positive	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Decreased appetite	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Diabetes mellitus	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Glucose tolerance impaired	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Gout	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	9.8% 5/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.0% 4/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	13.5% 7/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	21.4% 3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	17.1% 7/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Vitamin D deficiency	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	21.4% 3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	10.3% 4/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.8% 4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Arthritis	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	10.0% 5/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 8/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	13.9% 5/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	19.5% 8/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Bursitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Facet joint syndrome	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Amnesia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	9.8% 5/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.3% 3/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.6% 5/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	12.2% 5/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Diabetic neuropathy	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Dizziness	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.8% 4/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Headache	11.8% 6/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	12.0% 6/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	17.3% 9/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	11.1% 4/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	21.4% 3/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 3/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.6% 6/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Hypokinesia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Loss of consciousness	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Paraesthesia	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Nervous system disorders Sciatica	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Psychiatric disorders Adjustment disorder	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Psychiatric disorders Anxiety	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Psychiatric disorders Depression	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Psychiatric disorders Insomnia	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Acute kidney injury	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Dysuria	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Haematuria	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	14.3% 2/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Nephrolithiasis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Pollakiuria	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Renal cyst	5.9% 3/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Renal and urinary disorders Renal impairment	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Asthma	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	15.4% 2/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 4/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.8% 4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.8% 2/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	6.0% 3/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	8.3% 3/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Vascular disorders Hot flush	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Dermatitis contact	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Ecchymosis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Eczema	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.8% 1/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Hand dermatitis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Nail bed bleeding	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	1.9% 1/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.4% 1/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rash	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.8% 3/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.9% 2/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rosacea	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.1% 1/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	2.6% 1/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Skin haemorrhage	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Solar lentigo	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Vascular disorders Hypertension	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	4.0% 2/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	3.9% 2/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.6% 5/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.6% 2/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	5.1% 2/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	9.8% 4/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Vascular disorders Superficial vein thrombosis	2.0% 1/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/50 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/51 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/52 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/36 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/14 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/39 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	7.7% 1/13 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.	0.00% 0/41 • All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension). Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.

Additional Information

Patrick O'Brien, Chief Operating Officer

Arrowhead Pharmaceuticals, Inc.

Phone: 626-304-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
Publication restrictions are in place

Restriction type: OTHER