Trial Outcomes & Findings for Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed (NCT NCT03110380)

NCT ID: NCT03110380

Last Updated: 2022-01-11

Results Overview

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 567 participants
• Primary outcome timeframe: Week 48
• Results posted on: 2022-01-11

Participant Flow

Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 June 2017. The last study visit occurred on 10 Feb 2021.

633 participants were screened.

Participant milestones

Measure	B/F/TAF Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered orally once daily without regard to food for at least 48 weeks.	DTG + F/TAF DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	B/F/TAF From B/F/TAF Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	B/F/TAF From DTG + F/TAF Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Double-Blind Treatment Phase STARTED	284	283	0	0
Double-Blind Treatment Phase Safety Analysis Set	284	281	0	0
Double-Blind Treatment Phase COMPLETED	263	253	0	0
Double-Blind Treatment Phase NOT COMPLETED	21	30	0	0
Open-label B/F/TAF Extension Phase STARTED	0	0	125	116
Open-label B/F/TAF Extension Phase COMPLETED	0	0	121	113
Open-label B/F/TAF Extension Phase NOT COMPLETED	0	0	4	3

Reasons for withdrawal

Measure	B/F/TAF Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered orally once daily without regard to food for at least 48 weeks.	DTG + F/TAF DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	B/F/TAF From B/F/TAF Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	B/F/TAF From DTG + F/TAF Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Double-Blind Treatment Phase Withdrew Consent	10	16	0	0
Double-Blind Treatment Phase Lost to Follow-up	4	3	0	0
Double-Blind Treatment Phase Adverse Event	3	3	0	0
Double-Blind Treatment Phase Investigator's Discretion	1	3	0	0
Double-Blind Treatment Phase Death	2	1	0	0
Double-Blind Treatment Phase Non-Compliance with Study Drug	1	1	0	0
Double-Blind Treatment Phase Protocol Violation	0	1	0	0
Double-Blind Treatment Phase Randomized but not Treated	0	2	0	0
Open-label B/F/TAF Extension Phase Lost to Follow-up	0	0	3	1
Open-label B/F/TAF Extension Phase Withdrew Consent	0	0	1	1
Open-label B/F/TAF Extension Phase Adverse Event	0	0	0	1

Baseline Characteristics

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Baseline characteristics by cohort

Measure	B/F/TAF n=284 Participants B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	DTG + F/TAF n=281 Participants DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	Total n=565 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 11.3 • n=5 Participants	49 years STANDARD_DEVIATION 11.3 • n=7 Participants	50 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	245 Participants n=5 Participants	240 Participants n=7 Participants	485 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	68 Participants n=5 Participants	61 Participants n=7 Participants	129 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	200 Participants n=5 Participants	199 Participants n=7 Participants	399 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Permitted	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	61 Participants n=5 Participants	49 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	220 Participants n=5 Participants	229 Participants n=7 Participants	449 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Canada	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment Austria	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	197 Participants n=5 Participants	202 Participants n=7 Participants	399 Participants n=5 Participants
Region of Enrollment France	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Germany	30 Participants n=5 Participants	26 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Puerto Rico	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	276 Participants n=5 Participants	275 Participants n=7 Participants	551 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 copies/mL	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
CD4 Cell Count	714 Cells/μL STANDARD_DEVIATION 309.1 • n=5 Participants	658 Cells/μL STANDARD_DEVIATION 294.7 • n=7 Participants	686 Cells/μL STANDARD_DEVIATION 303.1 • n=5 Participants
CD4 Cell Count Category < 50 Cells/ μL	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
CD4 Cell Count Category ≥ 50 to < 200 Cells/μL	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
CD4 Cell Count Category ≥ 200 to < 350 Cells/μL	18 Participants n=5 Participants	34 Participants n=7 Participants	52 Participants n=5 Participants
CD4 Cell Count Category ≥ 350 to < 500 Cells/μL	53 Participants n=5 Participants	44 Participants n=7 Participants	97 Participants n=5 Participants
CD4 Cell Count Category ≥ 500 Cells/ μL	207 Participants n=5 Participants	196 Participants n=7 Participants	403 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Measure	B/F/TAF n=284 Participants B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	DTG + F/TAF n=281 Participants DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	0.4 percentage of participants	1.1 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Measure	B/F/TAF n=284 Participants B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	DTG + F/TAF n=281 Participants DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	93.3 percentage of participants	91.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 48

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

Outcome measures

Measure	B/F/TAF n=262 Participants B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.	DTG + F/TAF n=256 Participants DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for at least 48 weeks.
Change From Baseline in CD4+ Cell Count at Week 48	18 cells/µL Standard Deviation 179.1	36 cells/µL Standard Deviation 152.6

Adverse Events

Double-Blind Treatment Phase B/F/TAF

Serious events: 36 serious events

Other events: 181 other events

Deaths: 3 deaths

Double-Blind Treatment Phase DTG + F/TAF

Serious events: 27 serious events

Other events: 170 other events

Deaths: 2 deaths

Open-label Extension Phase B/F/TAF From B/F/TAF

Serious events: 12 serious events

Other events: 30 other events

Deaths: 0 deaths

Open-label Extension Phase B/F/TAF From DTG + F/TAF

Serious events: 11 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-Blind Treatment Phase B/F/TAF n=284 participants at risk B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.	Double-Blind Treatment Phase DTG + F/TAF n=281 participants at risk DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.	Open-label Extension Phase B/F/TAF From B/F/TAF n=125 participants at risk Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	Open-label Extension Phase B/F/TAF From DTG + F/TAF n=116 participants at risk Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Blood and lymphatic system disorders Lymphocytic infiltration	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Acute myocardial infarction	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.6% 2/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Angina pectoris	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Cardiac failure congestive	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Cardio-respiratory arrest	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Coronary artery disease	0.70% 2/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Myocardial infarction	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Sinus tachycardia	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Cardiac disorders Ventricular tachycardia	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Gastrointestinal disorders Colitis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Gastrointestinal disorders Inguinal hernia	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Gastrointestinal disorders Large intestine perforation	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Gastrointestinal disorders Vomiting	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
General disorders Chest pain	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
General disorders Death	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
General disorders Non-cardiac chest pain	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Hepatobiliary disorders Biliary dyskinesia	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Hepatobiliary disorders Cholangitis acute	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Hepatobiliary disorders Cholecystitis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Immune system disorders Anti-neutrophil cytoplasmic antibody positive vasculitis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Appendicitis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Bronchitis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Cellulitis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Cellulitis orbital	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Colonic abscess	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Covid-19 pneumonia	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Device related infection	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Diarrhoea infectious	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Diverticulitis	0.70% 2/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Epididymitis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Gastroenteritis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Meningitis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Perirectal abscess	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Pneumonia	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.71% 2/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.7% 2/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Post procedural infection	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Pyelonephritis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Sepsis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Wound infection	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Clavicle fracture	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Concussion	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Ligament rupture	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Lisfranc fracture	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Overdose	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Injury, poisoning and procedural complications Tendon rupture	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Investigations Blood glucose increased	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Investigations Lipase increased	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Investigations Liver function test increased	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Investigations Transaminases increased	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Metabolism and nutrition disorders Dehydration	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Myalgia	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Yolk sac tumour site unspecified	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Nervous system disorders Sciatica	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Nervous system disorders Seizure	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Nervous system disorders Vertebral artery dissection	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Psychiatric disorders Drug abuse	0.70% 2/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Psychiatric disorders Psychotic disorder	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Psychiatric disorders Rebound psychosis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.70% 2/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.36% 1/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.35% 1/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.

Other adverse events

Measure	Double-Blind Treatment Phase B/F/TAF n=284 participants at risk B/F/TAF (50/200/25 mg) FDC tablet + DTG placebo tablet + F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.	Double-Blind Treatment Phase DTG + F/TAF n=281 participants at risk DTG 50 mg tablet + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo tablet administered orally once daily without regard to food for atleast 48 weeks.	Open-label Extension Phase B/F/TAF From B/F/TAF n=125 participants at risk Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.	Open-label Extension Phase B/F/TAF From DTG + F/TAF n=116 participants at risk Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Gastrointestinal disorders Diarrhoea	9.2% 26/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	12.5% 35/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.2% 4/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	6.0% 7/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
General disorders Fatigue	7.7% 22/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.2% 9/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	6.0% 7/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Bronchitis	6.3% 18/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.0% 14/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.2% 4/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	4.3% 5/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Influenza	6.7% 19/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	6.0% 17/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.6% 2/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Nasopharyngitis	15.5% 44/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	11.4% 32/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	2.4% 3/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.86% 1/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Sinusitis	5.6% 16/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.9% 11/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.4% 4/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Infections and infestations Upper respiratory tract infection	11.6% 33/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	14.2% 40/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	7.2% 9/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	8.6% 10/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 24/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	7.5% 21/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.2% 4/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.4% 4/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Back pain	7.0% 20/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.3% 15/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.6% 2/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	2.6% 3/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 15/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.3% 15/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.4% 4/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Nervous system disorders Headache	5.6% 16/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	8.2% 23/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.4% 4/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Psychiatric disorders Insomnia	6.7% 19/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.0% 14/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.80% 1/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	2.6% 3/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Respiratory, thoracic and mediastinal disorders Cough	3.9% 11/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.7% 16/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.2% 4/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.7% 2/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Skin and subcutaneous tissue disorders Rash	3.2% 9/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	5.3% 15/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	1.7% 2/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.
Vascular disorders Hypertension	5.3% 15/284 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	3.9% 11/281 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	2.4% 3/125 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.	0.00% 0/116 • Adverse Events: First dose date up to last dose date [maximum: 84.9 weeks (Blinded Phase), 179.6 weeks (Open Label Phase) plus 30 days All-Cause Mortality: Randomization/Enrollment up to 187.7 weeks Adverse Events: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. All-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

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

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

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

Restriction type: OTHER