Trial Outcomes & Findings for A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects (NCT NCT02120352)

NCT ID: NCT02120352

Last Updated: 2024-06-12

Results Overview

Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 309 participants
• Primary outcome timeframe: Week 32
• Results posted on: 2024-06-12

Participant Flow

The study was conducted across 50 sites in five countries (United States, Canada, France, Germany and Spain). The results presented are based on final analysis, up to approximately Week 468.

Study consisted of 28 days Screening Period, 20 weeks Induction Period, 96 weeks Maintenance Period (MP), Extension Period (EP) and 52 weeks Long-Term Follow Up Period (LTFP). A total of 309 participants were enrolled in the study and entered the Induction Period, of which 288 completed and 286 were qualified and randomized into the MP.

Participant milestones

Measure	CAB 30 mg+ABC/3TC QD (Induction Period) In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).	Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Long-Term Follow-Up Group This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
Induction Period (20 Weeks) STARTED	309	0	0	0	0	0	0
Induction Period (20 Weeks) COMPLETED	288	0	0	0	0	0	0
Induction Period (20 Weeks) NOT COMPLETED	21	0	0	0	0	0	0
Maintenance Period (Up to Week 96) STARTED	0	115	115	56	0	0	0
Maintenance Period (Up to Week 96) COMPLETED	0	110	101	47	0	0	0
Maintenance Period (Up to Week 96) NOT COMPLETED	0	5	14	9	0	0	0
Extension Period (Week 97 to Study End) STARTED	0	107	101	0	34	10	0
Extension Period (Week 97 to Study End) COMPLETED	0	92	76	0	26	8	0
Extension Period (Week 97 to Study End) NOT COMPLETED	0	15	25	0	8	2	0
Long-Term Follow-up Period (52 Weeks) STARTED	0	0	0	0	0	0	43
Long-Term Follow-up Period (52 Weeks) COMPLETED	0	0	0	0	0	0	37
Long-Term Follow-up Period (52 Weeks) NOT COMPLETED	0	0	0	0	0	0	6

Reasons for withdrawal

Measure	CAB 30 mg+ABC/3TC QD (Induction Period) In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).	Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Long-Term Follow-Up Group This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
Induction Period (20 Weeks) Adverse Event	3	0	0	0	0	0	0
Induction Period (20 Weeks) Lack of Efficacy	5	0	0	0	0	0	0
Induction Period (20 Weeks) Protocol Violation	2	0	0	0	0	0	0
Induction Period (20 Weeks) Met protocol-defined stopping criteria	3	0	0	0	0	0	0
Induction Period (20 Weeks) Lost to Follow-up	2	0	0	0	0	0	0
Induction Period (20 Weeks) Withdrawal by Subject	5	0	0	0	0	0	0
Induction Period (20 Weeks) Physician Decision	1	0	0	0	0	0	0
Maintenance Period (Up to Week 96) Adverse Event	0	1	8	1	0	0	0
Maintenance Period (Up to Week 96) Lack of Efficacy	0	1	0	1	0	0	0
Maintenance Period (Up to Week 96) Protocol Violation	0	1	2	0	0	0	0
Maintenance Period (Up to Week 96) Met protocol-defined stopping criteria	0	0	1	1	0	0	0
Maintenance Period (Up to Week 96) Lost to Follow-up	0	0	0	1	0	0	0
Maintenance Period (Up to Week 96) Withdrawal by Subject	0	1	3	5	0	0	0
Maintenance Period (Up to Week 96) Physician Decision	0	1	0	0	0	0	0
Extension Period (Week 97 to Study End) Adverse Event	0	3	11	0	2	1	0
Extension Period (Week 97 to Study End) Lack of Efficacy	0	0	0	0	1	0	0
Extension Period (Week 97 to Study End) Protocol Violation	0	1	1	0	2	0	0
Extension Period (Week 97 to Study End) Withdrawal by Subject	0	7	9	0	2	0	0
Extension Period (Week 97 to Study End) Lost to Follow-up	0	2	1	0	1	0	0
Extension Period (Week 97 to Study End) Physician Decision	0	2	2	0	0	0	0
Extension Period (Week 97 to Study End) Site closed	0	0	1	0	0	1	0
Long-Term Follow-up Period (52 Weeks) Other	0	0	0	0	0	0	6

Baseline Characteristics

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

Baseline characteristics by cohort

Measure	CAB 30 mg+ABC/3TC QD n=309 Participants In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
Age, Continuous	36.6 Years STANDARD_DEVIATION 10.39 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	282 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American/African Heritage	46 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian - Central/South Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian - Japanese Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian - South East Asian Heritage	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White - Arabic/North African Heritage	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · White - White/Caucasian/European Heritage	240 Participants n=5 Participants
Race/Ethnicity, Customized Race · Mixed Race	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 32

Population: ITT-ME Population

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32	95 Percentage of participants	94 Percentage of participants	91 Percentage of participants

PRIMARY outcome

Timeframe: Up to Week 32

Population: ITT-ME Population

Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 20 weeks

Population: Safety Population. It consists of all enrolled subjects who received at least one dose of investigational product during induction period.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=309 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) Any non-SAE	246 Participants	—	—
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) Any SAE	8 Participants	—	—

PRIMARY outcome

Timeframe: Up to an average of 59 weeks

Population: Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of investigational product.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) Any non-SAE	115 Participants	113 Participants	52 Participants
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) Any SAE	9 Participants	8 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to an average of 59 weeks

Population: Safety Maintenance Population

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade Any AE with maximum toxicity Grade 1	31 Participants	25 Participants	19 Participants
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade Any AE with maximum toxicity Grade 2	67 Participants	72 Participants	29 Participants
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade Any AE with maximum toxicity Grade 3	15 Participants	14 Participants	3 Participants
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade Any AE with maximum toxicity Grade 4	2 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to an average of 59 weeks

Population: Safety Maintenance Population

Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters Maximum toxicity Grade 3	15 Participants	20 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters Maximum toxicity Grade 4	10 Participants	7 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters Maximum toxicity Grade 1	94 Participants	94 Participants	44 Participants
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters Maximum toxicity Grade 2	50 Participants	42 Participants	16 Participants

PRIMARY outcome

Timeframe: Up to an average of 59 weeks

Population: Safety Maintenance Population

Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters Maximum toxicity Grade 1	23 Participants	17 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters Maximum toxicity Grade 2	2 Participants	4 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters Maximum toxicity Grade 3	0 Participants	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters Maximum toxicity Grade 4	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to an average of 59 weeks

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=20 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=20 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=10 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Occult Blood, Trace, n=10,11,4	5 Participants	6 Participants	1 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Occult Blood, 1+, n=10,11,4	3 Participants	3 Participants	2 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Occult Blood, 2+, n=10,11,4	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Occult Blood, 3+, n=10,11,4	2 Participants	2 Participants	1 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Occult Blood, Positive, n=10,11,4	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Glucose, Trace, n=1,1,1	1 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Glucose, 1+, n=1,1,1	0 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Glucose, 2+, n=1,1,1	0 Participants	1 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Glucose, 3+, n=1,1,1	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Glucose, Positive, n=1,1,1	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Ketones, Trace, n=16,20,10	12 Participants	17 Participants	8 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Ketones, 1+, n=16,20,10	4 Participants	3 Participants	2 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Ketones, 2+, n=16,20,10	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Ketones, 3+, n=16,20,10	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Ketones, Positive, n=16,20,10	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Nitrite, Trace, n=1,3,1	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Nitrite, 1+, n=1,3,1	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Nitrite, 2+, n=1,3,1	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Nitrite, 3+, n=1,3,1	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Nitrite, Positive, n=1,3,1	1 Participants	3 Participants	1 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Protein, Trace, n=17,17,7	15 Participants	11 Participants	2 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Protein, 1+, n=17,17,7	2 Participants	4 Participants	5 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Protein, 2+, n=17,17,7	0 Participants	2 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Protein, 3+, n=17,17,7	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Protein, Positive, n=17,17,7	0 Participants	0 Participants	0 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Leukocyte, Trace, n=20,20,8	8 Participants	10 Participants	3 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Leukocyte, 1+, n=20,20,8	7 Participants	8 Participants	3 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Leukocyte, 2+, n=20,20,8	4 Participants	0 Participants	1 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Leukocyte, 3+, n=20,20,8	1 Participants	2 Participants	1 Participants
Number of Participants With Post-Baseline Urinalysis Dipstick Results Urine Leukocyte, Positive, n=20,20,8	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week -20, Week -16, Week -12, Week -8, Week -4, Day 1

Population: ITT-E Population

Percentage of participants with HIV-1 RNA <200 c/mL and <50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=309 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<50 c/mL, Week -20	0 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<50 c/mL, Week -16	72 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<50 c/mL, Week -12	90 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<50 c/mL, Week -8	89 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<50 c/mL, Week -4	92 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<50 c/mL, Day 1	91 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<200 c/mL, Week -20	0 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<200 c/mL, Week -16	94 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<200 c/mL, Week -12	97 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<200 c/mL, Week -8	96 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<200 c/mL, Week -4	94 Percentage of participants	—	—
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) HIV-1 RNA<200 c/mL, Day 1	94 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week -20, Week -16, Week -12, Week -8, Week -4, Day 1

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=309 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -20, n=309	4.43 Log10 copies per milliliter Standard Deviation 0.672	—	—
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -16, n=304	1.71 Log10 copies per milliliter Standard Deviation 0.229	—	—
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -12, n=302	1.62 Log10 copies per milliliter Standard Deviation 0.108	—	—
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -8, n=299	1.63 Log10 copies per milliliter Standard Deviation 0.281	—	—
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -4, n=294	1.61 Log10 copies per milliliter Standard Deviation 0.080	—	—
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Day 1, n=291	1.60 Log10 copies per milliliter Standard Deviation 0.070	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=304 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -16, n=304	-2.72 Log10 copies per milliliter Standard Deviation 0.572	—	—
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -12, n=302	-2.80 Log10 copies per milliliter Standard Deviation 0.640	—	—
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -8, n=299	-2.79 Log10 copies per milliliter Standard Deviation 0.665	—	—
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -4, n=294	-2.81 Log10 copies per milliliter Standard Deviation 0.647	—	—
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Day 1, n=291	-2.82 Log10 copies per milliliter Standard Deviation 0.645	—	—

SECONDARY outcome

Timeframe: Week -20, Week -16, Week -12, Week -4, Day 1

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=309 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -20, n=309	498.9 Cells per cubic millimeter Standard Deviation 180.67	—	—
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -16, n=304	630.5 Cells per cubic millimeter Standard Deviation 235.09	—	—
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -12, n=300	664.2 Cells per cubic millimeter Standard Deviation 256.57	—	—
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -4, n=292	702.3 Cells per cubic millimeter Standard Deviation 269.60	—	—
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Day 1, n=291	690.9 Cells per cubic millimeter Standard Deviation 261.63	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=304 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -16, n=304	131.7 Cells per cubic millimeter Standard Deviation 172.69	—	—
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -12, n=300	164.5 Cells per cubic millimeter Standard Deviation 174.61	—	—
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Week -4, n=292	201.5 Cells per cubic millimeter Standard Deviation 195.53	—	—
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Day 1, n=291	188.7 Cells per cubic millimeter Standard Deviation 186.69	—	—

SECONDARY outcome

Timeframe: Up to 20 Weeks

Population: Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of IP.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 1	27 Participants	—	—
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 2	15 Participants	—	—
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 3	2 Participants	—	—
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 4	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 20

Population: Safety Population. It consists of all enrolled subjects who received at least one dose of IP.

Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=309 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 1	26 Participants	—	—
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 2	4 Participants	—	—
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 3	1 Participants	—	—
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 4	3 Participants	—	—

SECONDARY outcome

Timeframe: Up to 20 weeks

Population: Safety Population

Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=309 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 1	130 Participants	—	—
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 2	50 Participants	—	—
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 3	16 Participants	—	—
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) Maximum toxicity Grade 4	5 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=306 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) CK, Week -16, n=306	19.0 International Units per Liter (IU/L) Standard Deviation 345.6	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) CK, Week -12, n=301	29.4 International Units per Liter (IU/L) Standard Deviation 485.4	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) CK, Week -8, n=297	26.3 International Units per Liter (IU/L) Standard Deviation 529.6	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) CK, Week -4, n=292	33.2 International Units per Liter (IU/L) Standard Deviation 434.2	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) CK, Day 1, n=287	69.9 International Units per Liter (IU/L) Standard Deviation 1164.7	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALT, Week -16, n=306	0.4 International Units per Liter (IU/L) Standard Deviation 33.1	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALT, Week -12, n=301	-1.3 International Units per Liter (IU/L) Standard Deviation 14.1	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALT, Week -8, n=297	-0.5 International Units per Liter (IU/L) Standard Deviation 16.6	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALT, Week -4, n=292	1.5 International Units per Liter (IU/L) Standard Deviation 50.3	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALT, Day 1, n=287	-1.2 International Units per Liter (IU/L) Standard Deviation 18.0	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALP, Week -16, n=306	-2.1 International Units per Liter (IU/L) Standard Deviation 12.0	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALP, Week -12, n=301	-2.6 International Units per Liter (IU/L) Standard Deviation 11.0	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALP, Week -8, n=297	-1.2 International Units per Liter (IU/L) Standard Deviation 13.0	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALP, Week -4, n=292	0.1 International Units per Liter (IU/L) Standard Deviation 15.4	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) ALP, Day 1, n=287	0.1 International Units per Liter (IU/L) Standard Deviation 14.1	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) AST, Week -16, n=306	0.3 International Units per Liter (IU/L) Standard Deviation 33.4	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) AST, Week -12, n=301	-2.2 International Units per Liter (IU/L) Standard Deviation 13.1	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) AST, Week -8, n=296	-1.7 International Units per Liter (IU/L) Standard Deviation 15.8	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) AST, Week -4, n=292	-0.0 International Units per Liter (IU/L) Standard Deviation 30.9	—	—
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) AST, Day 1, n=286	-1.0 International Units per Liter (IU/L) Standard Deviation 25.9	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=306 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) Week -16, n=306	0.2 Grams per Liter (G/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) Week -12, n=301	0.7 Grams per Liter (G/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) Week -8, n=297	1.4 Grams per Liter (G/L) Standard Deviation 2.6	—	—
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) Week -4, n=292	1.7 Grams per Liter (G/L) Standard Deviation 2.6	—	—
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) Day 1, n=287	1.9 Grams per Liter (G/L) Standard Deviation 2.8	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=306 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Total Bilirubin, Week -16, n=305	-0.6 Micromoles per Liter (umol/L) Standard Deviation 4.5	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Total Bilirubin, Week -12, n=301	-0.9 Micromoles per Liter (umol/L) Standard Deviation 4.0	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Total Bilirubin, Week -8, n=297	-1.0 Micromoles per Liter (umol/L) Standard Deviation 4.1	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Total Bilirubin, Week -4, n=292	-0.5 Micromoles per Liter (umol/L) Standard Deviation 4.1	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Total Bilirubin, Day 1, n=287	-0.3 Micromoles per Liter (umol/L) Standard Deviation 4.0	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Creatinine, Week -16, n=306	2.6 Micromoles per Liter (umol/L) Standard Deviation 7.6	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Creatinine, Week -12, n=301	1.5 Micromoles per Liter (umol/L) Standard Deviation 7.8	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Creatinine, Week -8, n=297	1.6 Micromoles per Liter (umol/L) Standard Deviation 7.8	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Creatinine, Week -4, n=292	3.5 Micromoles per Liter (umol/L) Standard Deviation 8.7	—	—
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) Creatinine, Day 1, n=287	4.6 Micromoles per Liter (umol/L) Standard Deviation 9.1	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=306 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) CO2, Week -16, n=306	0.2 Millimoles per Liter (mmol/L) Standard Deviation 2.4	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) CO2, Week -12, n=301	0.3 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) CO2, Week -8, n=296	0.4 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) CO2, Week -4, n=292	0.1 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) CO2, Day 1, n=286	-0.8 Millimoles per Liter (mmol/L) Standard Deviation 2.6	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Chloride, Week -16, n=306	0.2 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Chloride, Week -12, n=301	0.5 Millimoles per Liter (mmol/L) Standard Deviation 2.2	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Chloride, Week -8, n=297	0.6 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Chloride, Week -4, n=292	0.2 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Chloride, Day 1, n=287	0.2 Millimoles per Liter (mmol/L) Standard Deviation 2.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Cholesterol, Week -16, n=255	0.21 Millimoles per Liter (mmol/L) Standard Deviation 0.6	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Cholesterol, Week -12, n=236	0.19 Millimoles per Liter (mmol/L) Standard Deviation 0.5	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Cholesterol, Week -8, n=235	0.27 Millimoles per Liter (mmol/L) Standard Deviation 0.5	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Cholesterol, Week -4, n=282	0.34 Millimoles per Liter (mmol/L) Standard Deviation 0.5	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Cholesterol, Day 1, n=285	0.34 Millimoles per Liter (mmol/L) Standard Deviation 0.6	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Glucose, Week -16, n=255	0.07 Millimoles per Liter (mmol/L) Standard Deviation 0.7	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Glucose, Week -12, n=236	0.16 Millimoles per Liter (mmol/L) Standard Deviation 0.7	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Glucose, Week -8, n=235	0.08 Millimoles per Liter (mmol/L) Standard Deviation 0.7	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Glucose, Week -4, n=281	0.06 Millimoles per Liter (mmol/L) Standard Deviation 0.7	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Glucose, Day 1, n=282	-0.01 Millimoles per Liter (mmol/L) Standard Deviation 0.7	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Potassium, Week -16, n=306	-0.05 Millimoles per Liter (mmol/L) Standard Deviation 0.2	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Potassium, Week -12, n=301	-0.03 Millimoles per Liter (mmol/L) Standard Deviation 0.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Potassium, Week -8, n=296	0.03 Millimoles per Liter (mmol/L) Standard Deviation 0.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Potassium, Week -4, n=292	0.03 Millimoles per Liter (mmol/L) Standard Deviation 0.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Potassium, Day 1, n=286	0.03 Millimoles per Liter (mmol/L) Standard Deviation 0.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Sodium, Week -16, n=306	-0.1 Millimoles per Liter (mmol/L) Standard Deviation 1.8	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Sodium, Week -12, n=301	0.1 Millimoles per Liter (mmol/L) Standard Deviation 1.8	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Sodium, Week -8, n=297	0.2 Millimoles per Liter (mmol/L) Standard Deviation 1.9	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Sodium, Week -4, n=292	0.4 Millimoles per Liter (mmol/L) Standard Deviation 2.0	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Sodium, Day 1, n=287	0.3 Millimoles per Liter (mmol/L) Standard Deviation 1.9	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Triglyceride, Week -16, n=3	-0.69 Millimoles per Liter (mmol/L) Standard Deviation 0.1	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Triglyceride, Week -12, n=2	-0.37 Millimoles per Liter (mmol/L) Standard Deviation 0.1	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Triglyceride, Week -8, n=2	0.29 Millimoles per Liter (mmol/L) Standard Deviation 0.4	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Triglyceride, Week -4, n=278	0.20 Millimoles per Liter (mmol/L) Standard Deviation 0.9	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Triglyceride, Day 1, n=278	-0.00 Millimoles per Liter (mmol/L) Standard Deviation 0.7	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Urea, Week -16, n=306	-0.06 Millimoles per Liter (mmol/L) Standard Deviation 1.2	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Urea, Week -12, n=301	-0.08 Millimoles per Liter (mmol/L) Standard Deviation 1.2	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Urea, Week -8, n=297	-0.09 Millimoles per Liter (mmol/L) Standard Deviation 1.1	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Urea, Week -4, n=292	-0.12 Millimoles per Liter (mmol/L) Standard Deviation 1.3	—	—
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) Urea, Day 1, n=287	0.00 Millimoles per Liter (mmol/L) Standard Deviation 1.2	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=306 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) Week -16, n=306	3.3 Units per Liter (U/L) Standard Deviation 20.0	—	—
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) Week -12, n=301	0.8 Units per Liter (U/L) Standard Deviation 15.3	—	—
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) Week -8, n=297	2.8 Units per Liter (U/L) Standard Deviation 24.3	—	—
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) Week -4, n=292	2.1 Units per Liter (U/L) Standard Deviation 23.8	—	—
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) Day 1, n=288	-1.2 Units per Liter (U/L) Standard Deviation 17.7	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=303 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Basophils, Week -16, n=303	0.00 Giga cells per Liter Standard Deviation 0.016	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Basophils, Week -12, n=298	0.00 Giga cells per Liter Standard Deviation 0.019	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Basophils, Week -8, n=297	0.00 Giga cells per Liter Standard Deviation 0.015	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Basophils, Week -4, n=290	0.00 Giga cells per Liter Standard Deviation 0.016	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Basophils, Day 1, n=290	0.00 Giga cells per Liter Standard Deviation 0.019	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Eosinophils, Week -16, n=303	0.01 Giga cells per Liter Standard Deviation 0.131	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Eosinophils, Week -12, n=298	0.01 Giga cells per Liter Standard Deviation 0.123	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Eosinophils, Week -8, n=297	0.02 Giga cells per Liter Standard Deviation 0.127	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Eosinophils, Week -4, n=290	0.02 Giga cells per Liter Standard Deviation 0.136	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Eosinophils, Day 1, n=290	0.03 Giga cells per Liter Standard Deviation 0.161	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Lymphocytes, Week -16, n=303	0.24 Giga cells per Liter Standard Deviation 0.541	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Lymphocytes, Week -12, n=298	0.28 Giga cells per Liter Standard Deviation 0.573	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Lymphocytes, Week -8, n=297	0.30 Giga cells per Liter Standard Deviation 0.541	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Lymphocytes, Week -4, n=290	0.30 Giga cells per Liter Standard Deviation 0.574	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Lymphocytes, Day 1, n=290	0.14 Giga cells per Liter Standard Deviation 0.565	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Monocytes, Week -16, n=303	-0.00 Giga cells per Liter Standard Deviation 0.129	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Monocytes, Week -12, n=298	0.00 Giga cells per Liter Standard Deviation 0.139	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Monocytes, Week -8, n=297	-0.00 Giga cells per Liter Standard Deviation 0.135	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Monocytes, Week -4, n=290	-0.00 Giga cells per Liter Standard Deviation 0.132	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Monocytes, Day 1, n=290	0.00 Giga cells per Liter Standard Deviation 0.143	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Platelet count, Week -16, n=302	14.4 Giga cells per Liter Standard Deviation 31.56	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Platelet count, Week -12, n=300	18.2 Giga cells per Liter Standard Deviation 32.53	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Platelet count, Week -8, n=297	21.1 Giga cells per Liter Standard Deviation 37.00	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Platelet count, Week -4, n=290	23.0 Giga cells per Liter Standard Deviation 35.02	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Platelet count, Day 1, n=290	22.2 Giga cells per Liter Standard Deviation 35.32	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Total Neutrophils, Week -16, n=303	0.04 Giga cells per Liter Standard Deviation 1.185	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Total Neutrophils, Week -12, n=298	0.22 Giga cells per Liter Standard Deviation 1.391	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Total Neutrophils, Week -8, n=297	0.20 Giga cells per Liter Standard Deviation 1.286	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Total Neutrophils, Week -4, n=290	0.31 Giga cells per Liter Standard Deviation 1.429	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) Total Neutrophils, Day 1, n=290	0.38 Giga cells per Liter Standard Deviation 1.515	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) WBC, Week -16, n=303	0.31 Giga cells per Liter Standard Deviation 1.318	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) WBC, Week -12, n=298	0.52 Giga cells per Liter Standard Deviation 1.522	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) WBC, Week -8, n=297	0.54 Giga cells per Liter Standard Deviation 1.460	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) WBC, Week -4, n=290	0.64 Giga cells per Liter Standard Deviation 1.594	—	—
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) WBC, Day 1, n=290	0.57 Giga cells per Liter Standard Deviation 1.713	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=304 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) Week -16, n=304	0.00 Proportion of red blood cells in blood Standard Deviation 0.022	—	—
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) Week -12, n=302	0.00 Proportion of red blood cells in blood Standard Deviation 0.023	—	—
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) Week -8, n=298	0.00 Proportion of red blood cells in blood Standard Deviation 0.024	—	—
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) Week -4, n=290	0.00 Proportion of red blood cells in blood Standard Deviation 0.025	—	—
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) Day 1, n=290	0.00 Proportion of red blood cells in blood Standard Deviation 0.025	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=304 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) Week -16, n=304	0.8 Grams per Liter Standard Deviation 6.94	—	—
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) Week -12, n=302	2.0 Grams per Liter Standard Deviation 7.07	—	—
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) Week -8, n=298	2.5 Grams per Liter Standard Deviation 7.42	—	—
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) Week -4, n=290	3.3 Grams per Liter Standard Deviation 7.95	—	—
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) Day 1, n=290	3.1 Grams per Liter Standard Deviation 7.96	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=304 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) Week -16, n=304	1.0 Femtoliters Standard Deviation 1.52	—	—
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) Week -12, n=302	2.1 Femtoliters Standard Deviation 1.90	—	—
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) Week -8, n=298	3.1 Femtoliters Standard Deviation 2.49	—	—
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) Week -4, n=290	4.0 Femtoliters Standard Deviation 2.47	—	—
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) Day 1, n=290	4.4 Femtoliters Standard Deviation 2.57	—	—

SECONDARY outcome

Timeframe: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=304 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) Week -16, n=304	-0.05 10^12 cells per Liter Standard Deviation 0.242	—	—
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) Week -12, n=302	-0.07 10^12 cells per Liter Standard Deviation 0.254	—	—
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) Week -8, n=298	-0.10 10^12 cells per Liter Standard Deviation 0.266	—	—
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) Week -4, n=290	-0.10 10^12 cells per Liter Standard Deviation 0.284	—	—
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) Day 1, n=290	-0.14 10^12 cells per Liter Standard Deviation 0.289	—	—

SECONDARY outcome

Timeframe: From Day 1 up to Week 96

Population: ITT-ME Population

Percentage of participants with HIV-1 RNA <50 c/mL and <200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Day 1	95 Percentage of participants	99 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 4	97 Percentage of participants	98 Percentage of participants	93 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 8	98 Percentage of participants	97 Percentage of participants	95 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 12	96 Percentage of participants	97 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 16	97 Percentage of participants	96 Percentage of participants	89 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 20	97 Percentage of participants	97 Percentage of participants	91 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 24	96 Percentage of participants	94 Percentage of participants	91 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 28	90 Percentage of participants	92 Percentage of participants	86 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 32	95 Percentage of participants	94 Percentage of participants	91 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 36	95 Percentage of participants	90 Percentage of participants	88 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 40	92 Percentage of participants	91 Percentage of participants	86 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 44	93 Percentage of participants	90 Percentage of participants	88 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 48	92 Percentage of participants	91 Percentage of participants	89 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 56	94 Percentage of participants	90 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 64	95 Percentage of participants	90 Percentage of participants	86 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 72	95 Percentage of participants	90 Percentage of participants	88 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 80	95 Percentage of participants	87 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 88	95 Percentage of participants	86 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<50 c/mL, Week 96	94 Percentage of participants	87 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Day 1	100 Percentage of participants	100 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 4	99 Percentage of participants	100 Percentage of participants	96 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 8	99 Percentage of participants	99 Percentage of participants	95 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 12	97 Percentage of participants	98 Percentage of participants	98 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 16	98 Percentage of participants	98 Percentage of participants	93 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 20	98 Percentage of participants	97 Percentage of participants	93 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 24	97 Percentage of participants	96 Percentage of participants	93 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 28	94 Percentage of participants	95 Percentage of participants	91 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 32	97 Percentage of participants	95 Percentage of participants	91 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 36	97 Percentage of participants	93 Percentage of participants	89 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 40	97 Percentage of participants	92 Percentage of participants	86 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 44	95 Percentage of participants	91 Percentage of participants	89 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 48	97 Percentage of participants	92 Percentage of participants	89 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 56	96 Percentage of participants	90 Percentage of participants	86 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 64	96 Percentage of participants	90 Percentage of participants	88 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 72	96 Percentage of participants	90 Percentage of participants	88 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 80	96 Percentage of participants	88 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 88	96 Percentage of participants	86 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) HIV-1 RNA<200 c/mL, Week 96	96 Percentage of participants	87 Percentage of participants	84 Percentage of participants

SECONDARY outcome

Timeframe: At Week 32 and Week 48

Population: ITT-ME Population

Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) Week 32	1 Participants	0 Participants	1 Participants
Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) Week 48	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At Week 32 and Week 96

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.

Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented. SD=0.000 is defined as following: if participants analyzed at a specific timepoint have resulted same values, then SD is considered equal with 0.000.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=111 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) Week 32	1.60 Log10 copies per milliliter Standard Deviation 0.044	1.59 Log10 copies per milliliter Standard Deviation 0.025	1.61 Log10 copies per milliliter Standard Deviation 0.112
Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) Week 96	1.60 Log10 copies per milliliter Standard Deviation 0.056	1.59 Log10 copies per milliliter Standard Deviation 0.000	1.59 Log10 copies per milliliter Standard Deviation 0.000

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.

Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=111 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) Week 32	-2.78 Log10 copies per milliliter Standard Deviation 0.610	-2.88 Log10 copies per milliliter Standard Deviation 0.709	-2.73 Log10 copies per milliliter Standard Deviation 0.561
Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) Week 96	-2.77 Log10 copies per milliliter Standard Deviation 0.602	-2.89 Log10 copies per milliliter Standard Deviation 0.713	-2.77 Log10 copies per milliliter Standard Deviation 0.582

SECONDARY outcome

Timeframe: At Week 32 and Week 96

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) Week 32	752.3 Cells per cubic millimeter Standard Deviation 318.02	761.3 Cells per cubic millimeter Standard Deviation 293.07	891.3 Cells per cubic millimeter Standard Deviation 273.32
Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) Week 96	748.6 Cells per cubic millimeter Standard Deviation 253.41	750.0 Cells per cubic millimeter Standard Deviation 271.11	906.8 Cells per cubic millimeter Standard Deviation 288.77

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) Week 32	264.4 Cells per cubic millimeter Standard Deviation 247.84	263.7 Cells per cubic millimeter Standard Deviation 217.74	346.1 Cells per cubic millimeter Standard Deviation 219.59
Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) Week 96	257.5 Cells per cubic millimeter Standard Deviation 192.25	270.6 Cells per cubic millimeter Standard Deviation 210.99	369.9 Cells per cubic millimeter Standard Deviation 226.60

SECONDARY outcome

Timeframe: At Week 32 and Week 96

Population: ITT-ME Population

HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 1 to CDC Stage 3 Event, Week 32	1 Participants	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 2 to CDC Stage 3 Event, Week 32	0 Participants	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 3 to New CDC Stage 3 Event, Week 32	0 Participants	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 1, 2 or 3 to Death, Week 32	0 Participants	1 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 1 to CDC Stage 3 Event, Week 96	4 Participants	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 2 to CDC Stage 3 Event, Week 96	0 Participants	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 3 to New CDC Stage 3 Event, Week 96	0 Participants	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) From CDC Stage 1, 2 or 3 to Death, Week 96	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 32

Population: Safety Maintenance Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) Grade 1	35 Participants	29 Participants	23 Participants
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) Grade 2	65 Participants	69 Participants	22 Participants
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) Grade 3	14 Participants	13 Participants	1 Participants
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) Grade 4	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: Safety Maintenance Population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=56 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) Grade 1	23 Participants	21 Participants	24 Participants
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) Grade 2	71 Participants	74 Participants	26 Participants
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) Grade 3	19 Participants	18 Participants	4 Participants
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) Grade 4	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) ALT, Week 32	-2.4 International Units per Liter Standard Deviation 13.4	-2.7 International Units per Liter Standard Deviation 13.5	-5.0 International Units per Liter Standard Deviation 19.5
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) ALP, Week 32	-1.2 International Units per Liter Standard Deviation 14.6	-3.8 International Units per Liter Standard Deviation 15.0	-1.3 International Units per Liter Standard Deviation 11.6
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) AST, Week 32	-2.8 International Units per Liter Standard Deviation 12.5	-2.2 International Units per Liter Standard Deviation 14.5	-8.3 International Units per Liter Standard Deviation 30.6
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) CK, Week 32	51.4 International Units per Liter Standard Deviation 651.0	93.4 International Units per Liter Standard Deviation 446.9	38.8 International Units per Liter Standard Deviation 394.9
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) ALT, Week 96	1.8 International Units per Liter Standard Deviation 19.19	-2.2 International Units per Liter Standard Deviation 14.42	-2.7 International Units per Liter Standard Deviation 22.17
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) ALP, Week 96	-3.1 International Units per Liter Standard Deviation 15.59	-3.4 International Units per Liter Standard Deviation 15.64	-2.8 International Units per Liter Standard Deviation 12.34
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) AST, Week 96	-1.0 International Units per Liter Standard Deviation 15.45	-4.0 International Units per Liter Standard Deviation 9.31	-8.8 International Units per Liter Standard Deviation 32.57
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) CK, Week 96	21.1 International Units per Liter Standard Deviation 490.00	13.7 International Units per Liter Standard Deviation 153.92	-13.9 International Units per Liter Standard Deviation 227.98

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) Week 32	1.4 Grams per Liter Standard Deviation 3.0	0.9 Grams per Liter Standard Deviation 2.9	1.1 Grams per Liter Standard Deviation 2.8
Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) Week 96	1.0 Grams per Liter Standard Deviation 2.76	0.9 Grams per Liter Standard Deviation 2.87	0.2 Grams per Liter Standard Deviation 2.61

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) Total Bilirubin, Week 32	0.8 Micromoles per Liter Standard Deviation 4.4	0.4 Micromoles per Liter Standard Deviation 3.6	-0.6 Micromoles per Liter Standard Deviation 4.4
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) Creatinine, Week 32	2.7 Micromoles per Liter Standard Deviation 8.5	3.8 Micromoles per Liter Standard Deviation 8.7	2.7 Micromoles per Liter Standard Deviation 6.1
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) Total Bilirubin, Week 96	0.0 Micromoles per Liter Standard Deviation 3.78	-0.3 Micromoles per Liter Standard Deviation 4.11	-1.1 Micromoles per Liter Standard Deviation 4.25
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) Creatinine, Week 96	3.11 Micromoles per Liter Standard Deviation 8.515	4.27 Micromoles per Liter Standard Deviation 8.730	4.42 Micromoles per Liter Standard Deviation 6.105

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Total CO2, Week 32	-0.8 Millimoles per Liter Standard Deviation 2.1	-1.5 Millimoles per Liter Standard Deviation 2.4	-1.1 Millimoles per Liter Standard Deviation 2.4
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Chloride, Week 32	-0.2 Millimoles per Liter Standard Deviation 2.2	-0.3 Millimoles per Liter Standard Deviation 2.4	0.1 Millimoles per Liter Standard Deviation 2.1
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Cholesterol, Week 32	0.37 Millimoles per Liter Standard Deviation 0.6	0.47 Millimoles per Liter Standard Deviation 0.7	0.25 Millimoles per Liter Standard Deviation 0.5
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Glucose, Week 32	0.13 Millimoles per Liter Standard Deviation 1.0	0.03 Millimoles per Liter Standard Deviation 0.7	-0.05 Millimoles per Liter Standard Deviation 0.6
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Potassium, Week 32	0.01 Millimoles per Liter Standard Deviation 0.3	-0.05 Millimoles per Liter Standard Deviation 0.3	-0.04 Millimoles per Liter Standard Deviation 0.2
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Sodium, Week 32	0.4 Millimoles per Liter Standard Deviation 2.0	-0.1 Millimoles per Liter Standard Deviation 1.8	0.0 Millimoles per Liter Standard Deviation 1.7
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Triglycerides, Week 32	0.08 Millimoles per Liter Standard Deviation 0.9	-0.00 Millimoles per Liter Standard Deviation 1.7	0.06 Millimoles per Liter Standard Deviation 0.7
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Urea, Week 32	0.15 Millimoles per Liter Standard Deviation 1.3	0.23 Millimoles per Liter Standard Deviation 1.4	-0.01 Millimoles per Liter Standard Deviation 1.4
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Total CO2, Week 96	-0.8 Millimoles per Liter Standard Deviation 2.88	-1.1 Millimoles per Liter Standard Deviation 2.64	-0.1 Millimoles per Liter Standard Deviation 2.47
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Chloride, Week 96	-0.1 Millimoles per Liter Standard Deviation 2.32	-0.4 Millimoles per Liter Standard Deviation 2.53	0.3 Millimoles per Liter Standard Deviation 2.12
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Cholesterol, Week 96	0.554 Millimoles per Liter Standard Deviation 0.6724	0.731 Millimoles per Liter Standard Deviation 0.7380	0.348 Millimoles per Liter Standard Deviation 0.6490
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Glucose, Week 96	0.12 Millimoles per Liter Standard Deviation 0.729	0.11 Millimoles per Liter Standard Deviation 0.667	0.02 Millimoles per Liter Standard Deviation 0.745
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Potassium, Week 96	0.11 Millimoles per Liter Standard Deviation 0.378	-0.04 Millimoles per Liter Standard Deviation 0.408	-0.03 Millimoles per Liter Standard Deviation 0.314
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Sodium, Week 96	-0.1 Millimoles per Liter Standard Deviation 1.85	-0.4 Millimoles per Liter Standard Deviation 2.07	-0.4 Millimoles per Liter Standard Deviation 1.96
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Triglycerides, Week 96	0.084 Millimoles per Liter Standard Deviation 0.9000	0.080 Millimoles per Liter Standard Deviation 1.4964	0.197 Millimoles per Liter Standard Deviation 0.4972
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) Urea, Week 96	0.09 Millimoles per Liter Standard Deviation 1.393	-0.01 Millimoles per Liter Standard Deviation 1.230	0.12 Millimoles per Liter Standard Deviation 1.461

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=112 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) Week 32	-1.2 Units per Liter Standard Deviation 33.2	-4.4 Units per Liter Standard Deviation 15.4	-3.9 Units per Liter Standard Deviation 14.7
Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) Week 96	3.5 Units per Liter Standard Deviation 22.00	-0.8 Units per Liter Standard Deviation 14.73	-2.3 Units per Liter Standard Deviation 14.21

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=110 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=107 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=48 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Basophils, Week 32	0.00 10^9 cells per Liter Standard Deviation 0.012	-0.00 10^9 cells per Liter Standard Deviation 0.022	0.00 10^9 cells per Liter Standard Deviation 0.010
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Eosinophils, Week 32	0.01 10^9 cells per Liter Standard Deviation 0.146	0.23 10^9 cells per Liter Standard Deviation 1.985	-0.01 10^9 cells per Liter Standard Deviation 0.143
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Lymphocytes, Week 32	0.34 10^9 cells per Liter Standard Deviation 0.661	0.26 10^9 cells per Liter Standard Deviation 0.694	0.48 10^9 cells per Liter Standard Deviation 0.635
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Monocytes, Week 32	-0.02 10^9 cells per Liter Standard Deviation 0.152	-0.03 10^9 cells per Liter Standard Deviation 0.144	-0.00 10^9 cells per Liter Standard Deviation 0.144
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Platelet count, Week 32	18.7 10^9 cells per Liter Standard Deviation 38.28	20.6 10^9 cells per Liter Standard Deviation 44.93	11.6 10^9 cells per Liter Standard Deviation 33.33
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Total Neutrophils, Week 32	0.59 10^9 cells per Liter Standard Deviation 1.505	0.34 10^9 cells per Liter Standard Deviation 1.489	0.94 10^9 cells per Liter Standard Deviation 1.365
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) WBC count, Week 32	0.93 10^9 cells per Liter Standard Deviation 1.670	0.81 10^9 cells per Liter Standard Deviation 2.881	1.41 10^9 cells per Liter Standard Deviation 1.529
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Basophils, Week 96	0.004 10^9 cells per Liter Standard Deviation 0.0139	0.000 10^9 cells per Liter Standard Deviation 0.0204	0.006 10^9 cells per Liter Standard Deviation 0.0157
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Eosinophils, Week 96	0.015 10^9 cells per Liter Standard Deviation 0.1461	0.021 10^9 cells per Liter Standard Deviation 0.1013	-0.013 10^9 cells per Liter Standard Deviation 0.1528
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Lymphocytes, Week 96	0.325 10^9 cells per Liter Standard Deviation 0.6356	0.290 10^9 cells per Liter Standard Deviation 0.6793	0.534 10^9 cells per Liter Standard Deviation 0.5408
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Monocytes, Week 96	-0.009 10^9 cells per Liter Standard Deviation 0.1685	-0.014 10^9 cells per Liter Standard Deviation 0.1781	-0.005 10^9 cells per Liter Standard Deviation 0.1443
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Platelet count, Week 96	21.9 10^9 cells per Liter Standard Deviation 40.07	21.1 10^9 cells per Liter Standard Deviation 41.49	15.3 10^9 cells per Liter Standard Deviation 39.28
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) Total Neutrophils, Week 96	0.381 10^9 cells per Liter Standard Deviation 1.3060	0.515 10^9 cells per Liter Standard Deviation 1.6200	0.783 10^9 cells per Liter Standard Deviation 1.0747
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) WBC count, Week 96	0.72 10^9 cells per Liter Standard Deviation 1.545	0.82 10^9 cells per Liter Standard Deviation 1.786	1.31 10^9 cells per Liter Standard Deviation 1.144

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=111 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=107 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=48 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) Week 32	0.01 Proportion of red blood cells in blood Standard Deviation 0.026	0.01 Proportion of red blood cells in blood Standard Deviation 0.027	0.01 Proportion of red blood cells in blood Standard Deviation 0.027
Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) Week 96	0.0114 Proportion of red blood cells in blood Standard Deviation 0.02880	0.0134 Proportion of red blood cells in blood Standard Deviation 0.03125	0.0124 Proportion of red blood cells in blood Standard Deviation 0.02748

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=111 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=107 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=48 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) Week 32	2.0 Grams per Liter Standard Deviation 8.56	0.8 Grams per Liter Standard Deviation 8.45	1.7 Grams per Liter Standard Deviation 8.38
Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) Week 96	3.9 Grams per Liter Standard Deviation 8.95	4.3 Grams per Liter Standard Deviation 9.92	4.1 Grams per Liter Standard Deviation 8.11

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=111 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=107 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=48 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) Week 32	2.5 Femtoliters Standard Deviation 1.97	2.3 Femtoliters Standard Deviation 2.54	7.1 Femtoliters Standard Deviation 2.88
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) Week 96	0.1 Femtoliters Standard Deviation 2.99	0.3 Femtoliters Standard Deviation 2.54	5.3 Femtoliters Standard Deviation 3.14

SECONDARY outcome

Timeframe: At Week 32 and Week 96 (compared with Baseline [Week -20])

Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed

Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=111 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=107 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=48 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) Week 32	0.03 10^12 cells per Liter Standard Deviation 0.286	0.02 10^12 cells per Liter Standard Deviation 0.278	-0.20 10^12 cells per Liter Standard Deviation 0.296
Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) Week 96	0.12 10^12 cells per Liter Standard Deviation 0.294	0.14 10^12 cells per Liter Standard Deviation 0.310	-0.13 10^12 cells per Liter Standard Deviation 0.293

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) C0	1.43 Micrograms per milliliter Geometric Coefficient of Variation 54	2.35 Micrograms per milliliter Geometric Coefficient of Variation 32	—
Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) Cmax	3.55 Micrograms per milliliter Geometric Coefficient of Variation 56	3.50 Micrograms per milliliter Geometric Coefficient of Variation 39	—

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population

Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) C0	49.3 Nanograms per milliliter Geometric Coefficient of Variation 41	77.2 Nanograms per milliliter Geometric Coefficient of Variation 35	—
Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) Cmax	104 Nanograms per milliliter Geometric Coefficient of Variation 47	111 Nanograms per milliliter Geometric Coefficient of Variation 40	—

SECONDARY outcome

Timeframe: Pre-dose on Weeks 16, 24 and 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=87 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 16, n=87	1.6902 Micrograms per milliliter Standard Deviation 0.80471	—	—
Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 24, n=86	1.6051 Micrograms per milliliter Standard Deviation 0.78254	—	—
Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 32, n=84	1.5330 Micrograms per milliliter Standard Deviation 0.70822	—	—

SECONDARY outcome

Timeframe: Pre-dose on Weeks 16, 20, 24, 28 and 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=85 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 16, n=78	2.2703 Micrograms per milliliter Standard Deviation 0.92102	—	—
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 20, n=77	2.3861 Micrograms per milliliter Standard Deviation 0.76176	—	—
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 24, n=78	2.6342 Micrograms per milliliter Standard Deviation 1.29093	—	—
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 28, n=82	2.4365 Micrograms per milliliter Standard Deviation 0.86420	—	—
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 32, n=85	2.4715 Micrograms per milliliter Standard Deviation 0.89893	—	—

SECONDARY outcome

Timeframe: Pre-dose on Weeks 16, 24 and 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=87 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 16, n=87	41.94 Nanograms per milliliter Standard Deviation 17.575	—	—
Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 24, n=85	47.97 Nanograms per milliliter Standard Deviation 22.341	—	—
Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 32, n=83	57.24 Nanograms per milliliter Standard Deviation 22.926	—	—

SECONDARY outcome

Timeframe: Pre-dose on Weeks 16, 20, 24, 28 and 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=85 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 16, n=78	66.92 Nanograms per milliliter Standard Deviation 25.986	—	—
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 20, n=77	74.55 Nanograms per milliliter Standard Deviation 29.156	—	—
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 24, n=78	76.84 Nanograms per milliliter Standard Deviation 27.976	—	—
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 28, n=83	80.84 Nanograms per milliliter Standard Deviation 31.297	—	—
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) Week 32, n=85	90.34 Nanograms per milliliter Standard Deviation 34.549	—	—

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed.

Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC [0-tau]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).

Standard Error (SE)=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000 .

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=86 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=84 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) CAB LA	0.00 Change in log odds Standard Error 0.001	0.00 Change in log odds Standard Error 0.002	—
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) RPV LA	0.00 Change in log odds Standard Error 0.000	0.00 Change in log odds Standard Error 0.000	—

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=101 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) CAB LA, n=100,108, 50	0.64 Change in log odds Standard Error 0.837	2.39 Change in log odds Standard Error 1.903	0.39 Change in log odds Standard Error 0.528
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) RPV LA, n=101,104,49	0.00 Change in log odds Standard Error 0.025	0.01 Change in log odds Standard Error 0.039	-0.01 Change in log odds Standard Error 0.020

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "HIV-1 RNA<50 c/mL" (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=98 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=97 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) CAB LA, n=98, 97,0	-0.01 Change in log odds Standard Error 0.174	1.64 Change in log odds Standard Error 1.707	—
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) RPV LA, n=97,96,0	0.00 Change in log odds Standard Error 0.010	0.01 Change in log odds Standard Error 0.027	—

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed.

Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (AUC [0-tau]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau).

SE=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=86 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=84 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) CAB LA	-0.00 Change in log odds Standard Error 0.001	-0.00 Change in log odds Standard Error 0.002	—
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) RPV LA	0.00 Change in log odds Standard Error 0.000	-0.00 Change in log odds Standard Error 0.000	—

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=101 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=108 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) CAB LA, n=100,108, 50	-1.01 Change in log odds Standard Error 1.014	-2.39 Change in log odds Standard Error 1.903	-0.53 Change in log odds Standard Error 0.796
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) RPV LA, n=101,104,49	-0.00 Change in log odds Standard Error 0.027	-0.01 Change in log odds Standard Error 0.039	-0.01 Change in log odds Standard Error 0.038

SECONDARY outcome

Timeframe: Up to Week 32

Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is "virologic failure" and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=98 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=97 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) CAB LA, n=98, 97,0	-0.45 Change in log odds Standard Error 0.509	-1.64 Change in log odds Standard Error 1.707	—
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) RPV LA, n=97,96,0	-0.00 Change in log odds Standard Error 0.012	-0.01 Change in log odds Standard Error 0.027	—

SECONDARY outcome

Timeframe: Up to Week 32

Population: On-trt Genotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment genotypic resistance data, at time of protocol defined virologic failure.

Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor [NRTI], Non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI])are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=1 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=1 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Treatment-emergent Genotypic Resistance INI mutations	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Major mutations of other classes	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 32

Population: On-trt Phenotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment phynotypic resistance data, at time of protocol defined virologic failure.

Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=1 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=1 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With Treatment-emergent Phenotypic Resistance INI, Sensitive	1 Participants	—	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance INI, Partially sensitive	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance INI, Resistant	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance NNRTI, Sensitive	1 Participants	—	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance NNRTI, Partially sensitive	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance NNRTI, Resistant	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance NRTI, Sensitive	1 Participants	—	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance NRTI, Partially sensitive	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance NRTI, Resistant	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance PI, Sensitive	1 Participants	—	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance PI, Partially sensitive	0 Participants	—	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance PI, Resistant	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 32

Population: ITT-ME Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=99 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=94 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=49 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA<1000 c/mL, n=0,3,1	—	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13	100 Percentage of participants	84 Percentage of participants	92 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25	49 Percentage of participants	39 Percentage of participants	24 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10	87 Percentage of participants	100 Percentage of participants	90 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2	89 Percentage of participants	100 Percentage of participants	50 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5	86 Percentage of participants	100 Percentage of participants	80 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA<100000 c/mL, n=99,87,49	96 Percentage of participants	92 Percentage of participants	94 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7	88 Percentage of participants	100 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0	100 Percentage of participants	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8	97 Percentage of participants	100 Percentage of participants	88 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Baseline CD4+ count >=350 cells/mm^3, n=82,90,48	94 Percentage of participants	92 Percentage of participants	92 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Race-White, n=93,94,39	95 Percentage of participants	94 Percentage of participants	95 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) Race-Non-White, n=22,21,17	95 Percentage of participants	95 Percentage of participants	82 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) HC and not injectable drug user, n=98,90,40	96 Percentage of participants	94 Percentage of participants	90 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) No HC and not injectable drug user, n=17,25,16	88 Percentage of participants	92 Percentage of participants	94 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 32

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is < 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact [HC] and not injectable drug user).

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=99 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=94 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=49 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA<100000 c/mL, n=99,87,49	3 Percentage of participants	1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7	13 Percentage of participants	0 Percentage of participants	29 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA<1000 c/mL, n=0,3,1	—	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13	0 Percentage of participants	4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25	2 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10	9 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2	11 Percentage of participants	0 Percentage of participants	50 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5	14 Percentage of participants	0 Percentage of participants	20 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0	0 Percentage of participants	0 Percentage of participants	—
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8	0 Percentage of participants	0 Percentage of participants	13 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Baseline CD4+ count >=350 cells/mm^3, n=82,90,48	6 Percentage of participants	1 Percentage of participants	2 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Race-White, n=93,94,39	4 Percentage of participants	1 Percentage of participants	0 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) Race-Non-White, n=22,21,17	5 Percentage of participants	0 Percentage of participants	12 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) HC and not injectable drug user, n=98,90,40	3 Percentage of participants	1 Percentage of participants	5 Percentage of participants
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) No HC and not injectable drug user, n=17,25,16	12 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: At Week 32 and Week 96

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed

The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=109 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=106 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) Week 32	68.4 Scores on a scale Standard Deviation 4.48	66.6 Scores on a scale Standard Deviation 6.47	65.1 Scores on a scale Standard Deviation 5.83
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) Week 96	68.4 Scores on a scale Standard Deviation 4.34	67.0 Scores on a scale Standard Deviation 5.20	63.5 Scores on a scale Standard Deviation 9.75

SECONDARY outcome

Timeframe: Week 32

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed

The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=106 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=100 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=49 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period)	30.9 Scores on a scale Standard Deviation 7.56	28.9 Scores on a scale Standard Deviation 8.53	20.5 Scores on a scale Standard Deviation 14.09

SECONDARY outcome

Timeframe: Week 32

Population: ITT-ME Population. Only those participants available at the specified time points were analyzed

The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=109 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=106 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) n=50 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 0	80 Participants	73 Participants	16 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 1	12 Participants	14 Participants	13 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 2	3 Participants	2 Participants	2 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 3	2 Participants	6 Participants	3 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 4	0 Participants	1 Participants	1 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 5	2 Participants	4 Participants	12 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item E, score 6	10 Participants	6 Participants	3 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 0	40 Participants	33 Participants	29 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 1	35 Participants	43 Participants	12 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 2	17 Participants	16 Participants	2 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 3	6 Participants	5 Participants	2 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 4	7 Participants	3 Participants	3 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 5	4 Participants	4 Participants	0 Participants
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) Item F, Score 6	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 96

Population: Analysis was performed on the participants that received exclusively an oral regimen during the 96-weeks period \[CAB 30mg+ABC/3TC QD (Induction Period and Maintenance Period) group\], as pre-specified in Protocol.

The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 96 by their score categories (0: none of the time to 6: all of the time) are presented.

Outcome measures

Measure	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=46 Participants On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 0	18 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 1	10 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 2	3 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 3	2 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 4	1 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 5	9 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item E, score 6	3 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 0	3 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 1	8 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 2	4 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 3	1 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 4	0 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 5	1 Participants	—	—
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) Item F, Score 6	1 Participants	—	—

Adverse Events

CAB 30 mg+ABC/3TC QD (Induction Period)

Serious events: 8 serious events

Other events: 145 other events

Deaths: 1 deaths

CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)

Serious events: 31 serious events

Other events: 115 other events

Deaths: 0 deaths

CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)

Serious events: 31 serious events

Other events: 115 other events

Deaths: 3 deaths

CAB 30 mg+ABC/3TC QD

Serious events: 9 serious events

Other events: 52 other events

Deaths: 0 deaths

Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Long-Term Follow-Up Group

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	CAB 30 mg+ABC/3TC QD (Induction Period) n=309 participants at risk In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 participants at risk On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 participants at risk On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD n=56 participants at risk On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).	Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) n=34 participants at risk Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) n=10 participants at risk Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Long-Term Follow-Up Group n=43 participants at risk This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
Injury, poisoning and procedural complications Road traffic accident	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Cardiac disorders Myocardial infarction	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Uterine perforation	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Cellulitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Viral infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Arthritis infective	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations COVID-19	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Clostridium difficile infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Diverticulitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Herpes zoster	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Localised infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Malaria	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Pneumonia aspiration	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Pyelonephritis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Respiratory tract infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Septic shock	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Shigella infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Urosepsis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Drug abuse	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Adjustment disorder	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Bipolar I disorder	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Bipolar disorder	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Delirium	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Delusion	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Depression	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Depression suicidal	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Dissociation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Major depression	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Mania	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Psychiatric decompensation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Psychotic behaviour	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Suicidal ideation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Umbilical hernia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Abdominal hernia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Abdominal pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Anal fissure	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Enterocolitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Syncope	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Cognitive disorder	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Coma	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Dizziness	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Leukoencephalopathy	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Motor neurone disease	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Polyneuropathy alcoholic	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Sciatica	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Cardiac disorders Cardiogenic shock	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Cardiac disorders Acute myocardial infarction	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Cardiac disorders Angina unstable	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Cardiac disorders Myocardial ischaemia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Renal and urinary disorders Acute kidney injury	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Renal and urinary disorders Renal failure	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Blood and lymphatic system disorders Anaemia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Blood and lymphatic system disorders Splenic vein thrombosis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Vascular disorders Aortic dilatation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Vascular disorders Flushing	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Chest pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Hernia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Hepatobiliary disorders Hepatic failure	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Congenital, familial and genetic disorders Buried penis syndrome	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Metabolism and nutrition disorders Obesity	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Eye disorders Blindness	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Immune system disorders Eosinophilic granulomatosis with polyangiitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Hypobarism	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Reproductive system and breast disorders Prostatitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations COVID-19 pneumonia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Gastroenteritis viral	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Meningitis aseptic	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders VIth nerve paralysis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Vascular disorders Hypertension	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Suicide attempt	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	4.7% 2/43 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Abscess limb	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Anal abscess	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Epididymitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Epilepsy	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Headache	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Migraine	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Renal and urinary disorders Nephrolithiasis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Orchitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Overdose	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.7% 2/115 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Peritonsillar abscess	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Pneumonia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Epicondylitis	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Gastritis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Gastroenteritis	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.87% 1/115 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Nerve root compression	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Substance abuse	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Hepatobiliary disorders Drug-induced liver injury	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Multiple injuries	0.32% 1/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Seizure	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Hepatobiliary disorders Cholelithiasis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal neoplasm	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.9% 1/34 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Aggression	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Diarrhoea	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Pyrexia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Head injury	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Vascular disorders Haematoma	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.

Other adverse events

Measure	CAB 30 mg+ABC/3TC QD (Induction Period) n=309 participants at risk In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.	CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) n=115 participants at risk On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) n=115 participants at risk On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.	CAB 30 mg+ABC/3TC QD n=56 participants at risk On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).	Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period) n=34 participants at risk Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period) n=10 participants at risk Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.	Long-Term Follow-Up Group n=43 participants at risk This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
General disorders Injection site pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	96.5% 111/115 • Number of events 2749 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	99.1% 114/115 • Number of events 3533 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	91.2% 31/34 • Number of events 486 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	80.0% 8/10 • Number of events 197 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.3% 4/43 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site swelling	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	35.7% 41/115 • Number of events 209 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	37.4% 43/115 • Number of events 293 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.6% 6/34 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.0% 3/10 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site nodule	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	40.0% 46/115 • Number of events 327 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	49.6% 57/115 • Number of events 675 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	35.3% 12/34 • Number of events 34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	50.0% 5/10 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site induration	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	27.8% 32/115 • Number of events 156 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	28.7% 33/115 • Number of events 263 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site pruritus	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	34.8% 40/115 • Number of events 285 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	34.8% 40/115 • Number of events 305 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site warmth	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	27.8% 32/115 • Number of events 161 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	25.2% 29/115 • Number of events 218 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Fatigue	6.1% 19/309 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.5% 19/115 • Number of events 28 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Pyrexia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 23/115 • Number of events 33 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.4% 20/115 • Number of events 33 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 3/43 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site bruising	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.9% 24/115 • Number of events 65 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	15.7% 18/115 • Number of events 93 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Asthenia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.1% 9/56 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site erythema	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.4% 20/115 • Number of events 66 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 23/115 • Number of events 122 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Influenza like illness	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	13.0% 15/115 • Number of events 27 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site discolouration	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 20 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
General disorders Injection site haematoma	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 69 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Nasopharyngitis	8.7% 27/309 • Number of events 27 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	47.0% 54/115 • Number of events 129 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	47.0% 54/115 • Number of events 146 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	39.3% 22/56 • Number of events 39 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	23.5% 8/34 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	50.0% 5/10 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Upper respiratory tract infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	26.1% 30/115 • Number of events 55 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	24.3% 28/115 • Number of events 42 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.5% 7/56 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	26.5% 9/34 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Syphilis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	31.3% 36/115 • Number of events 61 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	24.3% 28/115 • Number of events 46 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.7% 6/56 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.0% 3/10 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Gastroenteritis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	24.3% 28/115 • Number of events 43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 23/115 • Number of events 36 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.9% 5/56 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	23.5% 8/34 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Bronchitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.5% 19/115 • Number of events 25 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	14.8% 17/115 • Number of events 26 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.7% 6/56 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.6% 6/34 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Pharyngitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.5% 19/115 • Number of events 25 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	18.3% 21/115 • Number of events 32 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.9% 5/56 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.6% 6/34 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Influenza	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	18.3% 21/115 • Number of events 26 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	27.8% 32/115 • Number of events 45 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.6% 7/34 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.0% 3/10 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Respiratory tract infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 17 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.7% 6/56 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Gonorrhoea	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	13.0% 15/115 • Number of events 25 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Rhinitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	13.9% 16/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Tonsillitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 15 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Oral herpes	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 28 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	14.8% 17/115 • Number of events 23 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Sinusitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 23 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.4% 12/115 • Number of events 18 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Urethritis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 16 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Conjunctivitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	13.0% 15/115 • Number of events 18 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Chlamydial infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Folliculitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Ear infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Viral infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Subcutaneous abscess	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Tooth infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 16 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Herpes zoster	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.4% 12/115 • Number of events 20 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	2.3% 1/43 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Gastroenteritis viral	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Proctitis chlamydial	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 18 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Tinea versicolour	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Urinary tract infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 21 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Anal chlamydia infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Onychomycosis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Oropharyngeal gonococcal infection	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 26 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Pneumonia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Proctitis gonococcal	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.4% 12/115 • Number of events 29 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Urethritis gonococcal	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Diarrhoea	11.0% 34/309 • Number of events 34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	33.9% 39/115 • Number of events 55 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.4% 35/115 • Number of events 59 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	19.6% 11/56 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.0% 3/10 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Nausea	12.3% 38/309 • Number of events 38 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 25 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.1% 9/56 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 3/43 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Abdominal pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 18 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Vomiting	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Dyspepsia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Constipation	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 15 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Odynophagia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Haemorrhoids	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 17 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.4% 12/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Proctitis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Anogenital dysplasia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Gastritis	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Gastrointestinal disorders Toothache	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 17 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Headache	8.7% 27/309 • Number of events 27 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	26.1% 30/115 • Number of events 51 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	26.1% 30/115 • Number of events 56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	25.0% 14/56 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Dizziness	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 16 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Nervous system disorders Sciatica	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	23.5% 27/115 • Number of events 39 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	26.1% 30/115 • Number of events 55 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.9% 10/56 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	23.5% 8/34 • Number of events 16 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.0% 3/10 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 18 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	1.8% 1/56 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	23.5% 27/115 • Number of events 45 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	18.3% 21/115 • Number of events 34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.6% 6/34 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	30.0% 3/10 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Insomnia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.5% 19/115 • Number of events 20 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 15 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Anxiety	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	19.1% 22/115 • Number of events 31 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	17.4% 20/115 • Number of events 24 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.1% 4/56 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Psychiatric disorders Depression	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	13.0% 15/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 15 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.9% 5/56 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Skin and subcutaneous tissue disorders Rash	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.7% 6/56 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	16.5% 19/115 • Number of events 26 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	22.6% 26/115 • Number of events 39 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.5% 7/56 • Number of events 8 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 5 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 17 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 18 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 20 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.4% 3/56 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.4% 12/115 • Number of events 15 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Contusion	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.3% 13/115 • Number of events 17 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Limb injury	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 19 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	15.7% 18/115 • Number of events 22 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.0% 8/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 11 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	12.2% 14/115 • Number of events 15 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.9% 2/34 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Vascular disorders Hypertension	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.7% 10/115 • Number of events 14 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Immune system disorders Seasonal allergy	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	9.6% 11/115 • Number of events 12 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	5.2% 6/115 • Number of events 6 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations COVID-19	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	21.7% 25/115 • Number of events 29 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	24.3% 28/115 • Number of events 34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	26.5% 9/34 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	20.0% 2/10 • Number of events 2 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Infections and infestations Suspected COVID-19	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 13 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	7.8% 9/115 • Number of events 9 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	6.1% 7/115 • Number of events 7 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/34 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Injury, poisoning and procedural complications Penis injury	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	8.8% 3/34 • Number of events 3 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/10 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/309 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/115 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/56 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	11.8% 4/34 • Number of events 4 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	10.0% 1/10 • Number of events 1 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.	0.00% 0/43 • All-cause mortality, SAEs and non-SAEs were collected from start of the study treatment up to end of Extension and LTFU Periods (up to approximately 468 weeks). Safety population included all randomized participants who received at least one dose of study drug, based on the study phase they were included in.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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